Fast Five Medtech News Podcast
MassDevice
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Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up to date on the latest breakthroughs in medical technology with the top five news stories to get your day started. Subscribe and join us every weekday for your daily medtech news roundup.
Available episodes
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1 day ago
Edwards to spin off critical care unit, Medtronic terminates deal to acquire EOFlow
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, Dec. 8, 2023.
Check out the show notes at massdevice.com/podcast.
Beta Bionics became the second company in as many days to launch an automated insulin pump with the Dexcom G7 CGM. Fast Five hosts Jim Hammerand and Sean Whooley dive into the latest news and break down the key features of the iLet bionic pancreas.
Distalmotion selected a former Zimmer Biomet executive to take over as its new CEO. The hosts look into the background of the new figure in the corner office and discuss the Dexter surgical robot platform as the company prepares for its next phase of growth.
BD has a new alternative to the traditional venous blood drawing method following FDA clearance for its MiniDraw device. Hammerand and Whooley explain what sets this device apart from other methods and why it could usher in a new era of diagnostics.
Medtronic made waves earlier this year when it agreed to acquire insulin patch pump maker EOFlow, but that deal is now off after the medtech giant terminated their acquisition agreement. The hosts discuss the reasons behind Medtronic's decisions and the potential ramifications on the insulin delivery market.
Edwards is the latest big-name medtech company to join the spin-off trend, announcing plans to spin its critical care business. Hammerand and Whooley take a look at Edwards' reasoning behind the decision and the areas in which the company now plans to focus once it completes the separation.
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2 days ago
Tandem integrates Dexcom G7 into insulin pumps, Medtronic wins CE mark for neurostim tech
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, Dec. 7, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Merit Medical upsized a private placement to $650 million and could bring in as much as $725 million from the offering. Fast Five hosts Jim Hammerand and Sean Whooley look at the details of the offering, as well as Merit's potential plans with the proceeds.
The hosts look at a major reimbursement win for Ambu, breaking down some of the features of the company's single-use bronchoscope technology and why CMS decided to allow incremental reimbursement for outpatient procedures.
Levita Magnetics announced the completion of the first procedures outside the U.S. with its surgical robotic technology. Hear all about the magnetic-based MARS platform, the surgeries that took place in South America and what this milestone means to Levita's CEO.
Medtronic earned CE mark for the latest device in its Precept family of deep brain stimulation implants. While it remains investigational in the U.S., the hosts look at what this implant brings to the European market as a first-of-its-kind offering.
In a milestone announcement for diabetes technology, Tandem Diabetes Care and Dexcom say they launched an integrated artificial pancreas system using Tandem's pump technology and Dexcom's next-generation G7 CGM. Whooley and Hammerand explain the significance of this integration and the benefits for users of the technology.
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3 days ago
J&J MedTech says new products will fuel growth; FDA clears Exactech ankle surgery navigation
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, December 6, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Rockley Photonics has begun sampling its biosensing wearable. Fast Five hosts Danielle Kirsh and Sean Whooley discuss what the wearable will measure, some of the design components and how optimistic executives are feeling.
EndoQuest raised $42 million for its endoluminal robotic technology. Learn what the funds will go toward and what technology EndoQuest is developing.
Johnson & Johnson's Ethicon has settled its remaining Physiomesh lawsuits. Whooley goes over what the judge on this case decided, how many cases Ethicon has been dealing with and what its response was to the judge's decision.
Exactech won FDA clearance for its new ankle surgery navigation system. Hear what the system is designed for and what doctors think about the system's performance in today's episode.
Johnson & Johnson MedTech thinks new products will fuel growth for the company. Whooley and Kirsh discuss where J&J MedTech stands in the medtech market, what the new leader sees for the future of the medtech segment and what will drive value in the future.
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4 days ago
Three medtech companies recall and warn on infusion pumps, Nevro acquires Vyrsa
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, Devember 5, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Intuitive Ventures brought in another $150 million in funding to support minimally invasive care startups. Fast Five hosts Sean Whooley and Danielle Kirsh discuss Intuitive Ventures' background and what its goal is for improving care.
Aptar won an FDA contract to study low global warming potential metered dose inhalers. Learn more about this initiative and how Aptar will support the FDA in this episode.
GE HealthCare and AirStrip are partnering on patient monitoring and cardiac data visualization. Whooley explains what each company brings to this collaboration and what AirStrip's technology does.
Nevro announced it acquired joint fusion device maker Vyrsa and closed a credit facility and refinancing. Hear more about the acquisition, including how Vyrsa supplements Nevro's portfolio.
Three medtech companies issued warnings or recalls on some infusion pumps. Kirsh and Whooley talk about the three separate issues and how they all differ. Read more about BD's recall, Baxter's warning and Eitan Medical's recall.
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Dec 1, 2023
J&J makes a $400M acquisition; U.S. lawmakers want SEC probe into Elon Musk's Neuralink
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, December 1, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Procyrion has enrolled its first patients in the investigational device exemption trial of the company's mechanical circulatory support technology. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the technology and what the company plans to study during the trial.
BD launched its SiteRite vascular access ultrasound system as part of its One-Stick hospital stay initiative. Hear what the system does and how it improves clinician efficiency.
After its landmark FDA approval, Medtronic has announced the first cases using its Symplicity Spyral renal denervation system. Whooley talks about how the procedures went and what doctors who used the tech thought about its performance.
Elon Musk is denying monkey death claims at his brain-computer interface company Neuralink and the U.S. government wants an SEC probe into the company. The Fast Five hosts talk about the issues Neuralink has had recently, Musk's comments on the monkey deaths and why the U.S. government wants an SEC investigation.
Johnson & Johnson MedTech made a play in the LAA device space with the $400 million acquisition of Laminar. Learn some of the deal's details and what makes Laminar's technology so unique.
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Nov 30, 2023
FDA warns of thermal issues with Philips DreamStation 2 CPAP machines
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 30.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Zilia this week won an FDA 510(k) clearance for a retinal camera. Fast Five hosts Danielle Kirsh and Sean Whooley explain what the retinal camera is designed for, how it works and what's next for the company.
ReValve reported one of the first successful first-in-human implants for its next-gen transcatheter mitral valve replacement. Hear about the procedures and what doctors thought about using the valve replacement.
BiVacor received investigational device exemption from the FDA to begin feasibility studies of its artificial heart. Whooley details the technology that goes into the artificial heart and some of the plans behind the upcoming studies.
The first patient was enrolled in Penumbra's study of its computer-assisted vacuum thrombectomy system. Learn more about the system in today's episode and what this trial will evaluate.
Philips has announced thermal issues with some of its DreamStation 2 CPAP machines. Kirsh and Whooley talk about the latest warning from the FDA, the risks involved with using the device and Philips' response.
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Nov 29, 2023
Henry Schein has more cybersecurity disruptions, Orthofix has a new CEO
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 29, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Scottish startup 1nhaler raised $2.5 million as it looks to advance its sustainable single-use dry powder inhaler technology. Fast Five hosts Sean Whooley and Danielle Kirsh break down the plans for the company attempting to disrupt the drug delivery space.
The good news continues to come for ReWalk Robotics, which announced that it demonstrated proof-of-concept for its next-generation, AI-powered exoskeleton technology. The hosts look into the importance of this milestone, which follows a major reimbursement win.
GE HealthCare received FDA clearance for a new critical care algorithm that helps detect, notify and triage the diagnosis of pneumothorax. Listen to learn more about what this technology does and why it has company officials excited about its potential impact.
Following a mass executive exodus that included the termination of the CEO and CFO, Orthofix has a new leader more than two months later. The company picked a new CEO and had news about the future of its board chair who led the company in an interim capacity. The hosts explain the background of this situation, outline the new CEO's career history and look at what's next for Orthofix.
Henry Schein's cyberattack struggles continue as the threat actor from the company's recent breach caused another disruption. This one led to an outage of the company's ecommerce platform. The Fast Five hosts take a look at the latest problems for Henry Schein and the impact on the company's business.
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Nov 28, 2023
What’s next for Medtronic’s RDN program after FDA approval?
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 28, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Philips this week unveiled its next-generation ultrasound systems. Fast Five hosts Sean Whooley and Danielle Kirsh go over the details of some of the new ultrasound systems and the executives' optimism.
Pristine Surgical has fully launched its single-use arthroscope in the U.S. Hear what the system does, how the system integrates into existing clinical workflows and the reaction from doctors so far.
Medtronic launched its left atrial appendage exclusion system. Whooley explains how the LAA system works and how it gives surgeons greater control during procedures.
GE HealthCare also unveiled new technology this week – an AI-powered breast cancer detection suite. The Fast Five hosts discuss what the suite does, what AI and software is integrated in the suite and how optimistic executives are about the future of breast cancer diagnostics.
Before we went on holiday break, the FDA approved Medtronic's renal denervation system. With the approval under its belt, Medtronic has big plans for the system's launch. Find out what those plans are and how it plans to achieve them.
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Nov 17, 2023
3M chooses a name for the Health Care spinoff; Baxter has a Class I recall of some syringe pumps
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 17.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Surmodics this week announced positive data for multiple drug-coated balloons. Fast Five hosts Sean Whooley and Danielle Kirsh talk about what the company was studying and some of the key data points that stuck out in the results.
NeuroOne is pursuing drug delivery with neural probe technology. Hear how the company is making that step and what the CEO had to say about entering this new venture.
Inari Medical closed the previously announced acquisition of LimFlow. Whooley shares the financial details and how LimFlow's technology will supplement what Inari Medical is already doing.
Baxter has a Class I recall of some syringe pumps due to an underdosing risk. Find out the reason behind the recall and what kinds of risks are involved with continued use of the devices.
3M has chosen the name for its Health Care spinoff. The Fast Five hosts discuss the new company name, the rationale behind the name and logo and how other companies have handled spinoffs in recent years.
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Nov 16, 2023
Beta Bionics earns big pharmacy benefit win for bionic pancreas; NeuroOne names new COO
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 16, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Alcon stocks dipped on Wednesday as it released its Q3 earnings. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the financial highlights of the quarter and the company's expectations for the full-year upon these results.
Ethicon has unveiled a hemostatic sealing patch in Europe. Whooley explains the technology behind the patch and the company's plans for a launch in the future.
Virtuoso Surgical won an NIH funding grant to support its surgical robot. Hear what the surgical robot does and what the company wants to do with the funding grant.
NeuroOne named a former Cardiovascular System VP as its new COO. The Fast Five hosts discuss who is taking over in this role, their career history and the optimism they bring to the company.
Beta Bionics won a pharmacy benefit for its bionic pancreas. Whooley talks about what the decision means for Beta Bionics and how it differs from the insurance benefits of insulin pumps.
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Nov 15, 2023
Vicarious Surgical has more layoffs, Medtronic's stolen scope recall is Class I
Day Zero Diagnostics and Oxford Nanopore today announced a collaboration to develop a solution for diagnosing bloodstream infections. Fast Five hosts Jim Hammerand and Sean Whooley dive into the details of the partnership.
Asensus Surgical inked a manufacturing deal with Flex for services around its next-generation surgical robot platform. Listen for the details of the partnership and some other news about Asensus' other surgical robotic offerings.
Johnson & Johnson MedTech followed up its Ottava news from last week with a regulatory win for a different surgical robot in China. The hosts unpack what the company's Monarch robot does and why its latest milestone is significant.
The FDA says the recall of stolen, defective Medtronic laryngoscopes is Class I, the most serious kind. Hear all the details of this recall, including how third parties are attempting to profit from these stolen devices.
Vicarious Surgical is cutting its headcount again as it pushed back the development timeli…
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Nov 14, 2023
ResMed restructures leadership team, Henry Schein updates on cyberattack
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 14, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Just one week after winning FDA approval, Recor Medical reported the first commercial cases with its renal denervation treatment for hypertension. Fast Five hosts Sean Whooley and Jim Hammerand break down the details of the initial procedures and discuss how Recor got to this point.
Eko shared new clinical data demonstrating the real-world clinical efficacy of its AI-enabled Sensora platform. Hear about how the heart disease detection platform performed compared to a standard analog stethoscope.
Olympus initiated a voluntary field corrective action following reports of endobronchial combustion incidents involving bronchoscopes. The hosts discuss the ramifications of this issue and the i…
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Nov 10, 2023
Acutus Medical is laying off more than half its workers, 3M Health Care group president is leaving
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 10, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
BD posted mixed Q4 earnings this week that resulted in its stock falling on Thursday. Fast Five hosts Sean Whooley and Danielle Kirsh go over the financial results for the quarter and how some of the individual segments performed.
Elucid raised $80 million in a Series C fundraising round for its AI-powered imaging analysis software. Hear what the funding will go toward and what the company's software does.
The FDA recently cleared Owlet's over-the-counter pulse oximetry sock for infants. Find out more about the device and some of the regulatory nods the company already had.
3M Health Care Group President Jeff Lavers is leaving the company ahead of the planned spinoff. Whooley gives…
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Nov 9, 2023
Recor Medical wins first FDA nod for renal denervation. Is Medtronic next?
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 9, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Xenter this week unveiled its new dual-sensor guidewire for TAVR procedures. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the technology and what its designed to do.
An independent committee apart of NICE has recommended automated insulin delivery technology rollouts in the U.K. Hear what the committee recommended exactly and what major diabetes companies think.
GE HealthCare and Masimo are collaborating on patient monitoring technology. Whooley explains the goal of the partnership and how they plan to achieve that goal.
Abbott has launched in the first procedures its dual-chamber pacemaker in the U.S. Find out what the technology does and what doctors think about it.…
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Nov 8, 2023
J&J plans to submit Ottava surgical robot for FDA IDE next year
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 8, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
Enable Injections this week announced it added a finance veteran to its board of directors. Fast Five hosts Danielle Kirsh and Sean Whooley discuss the new addition and the optimism they bring to the table.
Onward's spinal cord stimulation demonstrated improved mobility in patients with Parkinson's disease, according to a new study. Whooley shares the key points of the study and the reaction of participants that were in the study.
Cordis announced its new CEO. Find out who is taking over the corner office.
Philips received significant funding from the Gates Foundation for AI-powered maternal health ultrasounds. Hear how the funding will support underserved communities.
Johnson & John…
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Nov 7, 2023
Cyber gang threatens to release Henry Schein data in ransomware attack
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 7, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
HistoSonics scored a reimbursement win for its sonic beam therapy. Fast Five hosts Danielle Kirsh and Sean Whooley explain what this means for the company and what the therapy is designed to do.
Johnson & Johnson's Ethicon announced an AI-powered laparoscopic training technology at a recent conference. Hear what the technology does, what the platform offers and what executives are saying.
Asensus has initiated a Senhance program in Germany, expanding further in Europe. Whooley explains some of the companies previous program announcements and the optimism that executives have.
Siemens Healthineers Diagnostics is laying off hundreds of employees in the U.S. The Fast Five hosts discuss…
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Nov 3, 2023
Avail Medsystems abruptly shuts down; Cooper Cos. buys some of Cook Medical's product lines
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 3, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Biosense Webster this week posted positive data for its QDOT Micro ablation catheter. Fast Five hosts Sean Whooley and Danielle Kirsh go over some of the key data points that stuck out from the study and the optimism that executives have with this news.
Silk Road Medical named its new CEO after Erica Rogers announced her intent to retire. Find out who is taking over the corner office and their career history.
Inari Medical plans to purchase LimFlow Medical for up to $415 million. Whooley explains the details of the deal and how it supplements Inari Medical's strategy.
Avail Medsystems is shutting down. The Fast Five hosts discuss the reason behind the shutdown and the technology the c…
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Nov 2, 2023
Major diabetes companies launch initiatives for Diabetes Awareness Month
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 2, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Corin Group won an FDA clearance for its surgical robotics platform. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the surgical robotic platform does and what the company hopes to achieve using artificial intelligence.
SiBionics won CE mark approval for a 14-day continuous glucose monitoring system. Whooley details what the CGM does and the company's operations and plans for manufacturing the system.
DarioHealth launched a smart blood sugar meter for the iPhone 15. Hear how the meter works and what optimism the executives have about the future of the company.
Intuitive Surgical appointed an Align Technology executive to its board of directors. The Fast Five hosts di…
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Nov 1, 2023
J&J's DePuy is laying off workers, Abbott teams up with NFL player Damar Hamlin
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 1, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
GE HealthCare posted third-quarter earnings this week. Fast Five hosts Sean Whooley and Danielle Kirsh go over some of the financial details for the quarter and how individual segments performed.
Stereotaxis announced the first surgical robot procedure with Abbott's cardiac mapping technology. Hear what procedures it was used in and what doctors thought about the success of the procedures.
The first U.S. procedures using ZimeVie's 4.5mm Mobi-C device were also announced this week. Whooley details what surgeons thought about using the implant in these procedures.
Abbott is teaming up with NFL player Damar Hamlin for its 'Heartmates Program.' The Fast Five hosts discuss Hamlin's optimis…
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Oct 31, 2023
Philips CEO reportedly approved continued sale of defective sleep respiratory devices
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 31, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Cardio Flow this week announced the first commercial cases using its Freedom Flow device and appointed a new chief operating officer. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the device does, as well as the new executive appointment and some of their career history.
Cognito Therapeutics appointed a new chief commercial officer this week. Whooley goes over the new appointee's career history, their optimism upon joining the neuromod tech developer and what other executives think.
The FDA has cleared a non-invasive insomnia treatment device from Neurovalens. Find out what this device is, how it works and what executives think about the future of the device.
The FDA…
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Oct 27, 2023
Accuray is laying off some employees; How Abbott made accessible and affordable CGMs
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 27, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Boston Scientific has posted Q3 financial results this week and raised its EPS guidance. Fast Five hosts Sean Whooley and Danielle Kirsh discuss which segments performed well and what the company expects financially for the remainder of the year.
Tandem Diabetes Care announced positive data on its artificial pancreas technology. Whooley shares the data points that stuck out the most to him and what Tandem's technology does.
Edwards won CE mark approval for its Mitris Resilia valve. Learn more about the valve, some of its features and what executives are thinking as the announcement comes at an interesting time for the company.
Abbott shared a story about how it developed an accessible…
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Oct 26, 2023
Medtronic picks Ireland for renal denervation tech manufacturing, McEvoy exits AdvaMed board
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 26, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
Abbott this week reported positive data for its MitraClip and TriClip devices. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the most compelling data from the results and what executives think.
A Boston Scientific executive is joining the board of directors at Day Zero Diagnostics. Hear who is taking a board seat and why.
Fresenius Medical Care has a Class I recall of some hemodialysis systems. Find out which devices are affected and what the company is doing to fix the issue.
Ashely McEvoy's departure from Johnson & Johnson means she has to step down from her role as board chair of AdvaMed. Whooley details if the trade organization has chosen a replacement and what AdvaMed CEO…
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Oct 25, 2023
Ashley McEvoy is leaving J&J MedTech, 3M Health Care spinoff expected in early 2024
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 25, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
The first commercial cases using Levita Magnetics' surgical robot were recently announced. Fast Five hosts Sean Whooley and Danielle Kirsh detail what the surgical robot does and what doctors think about the robot.
Moon Surgical also announced the first commercial cases in France of its Maestro surgical robot. Hear what procedures it was used in and what surgeons thought about its use.
Butterfly Network is looking to make a move in the BCI space. Whooley talks about the company's latest partnership to boost the use in brain-computer interfaces and what executives think.
The 3M Health Care spinoff is on track to be completed in early 2024. The Fast Five hosts discuss the optimism 3M exec…
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Oct 24, 2023
Medtronic wins FDA nod for extravascular defibrillator, Philips raises outlook in Q3 earnings
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 24, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
We are back for a new episode of the Fast Five after a week-long hiatus to focus on our DeviceTalks West conference in Santa Clara, California. Before we jump into the news you should know for today, we would be remiss if we didn't talk about the biggest stories from last week – J&J MedTech is restructuring its orthopedics business, and there's finally some insight into what caused the EU antitrust probe into Edwards Lifesciences' business. We break down the news we missed last week and more to get the show started. Plus, you can find all coverage from DeviceTalks West on MassDevice and on our sister site Medical Design & Outsourcing.
This week, GE HealthCare announced a cardiac imaging…
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Oct 13, 2023
EU orders Illumina to divest Grail after 'unlawful' merger
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 13, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Orthofix launched its OsteoCove bioactive synthetic graft. Fast Five hosts Danielle Kirsh and Jim Hammerand discuss the features of the device and what executives are thinking about the launch.
Medtronic won CE mark approval for its Evolut FX TAVI. Hear what doctors think about the device and what makes it unique compared to other devices in the Evolut portfolio.
Getinge is making an infection prevention play with its latest acquisition of Healthmark. Get the financial details of the detail and how it will help Getinge's business in the long run.
A judge has granted preliminary approval to Philips' class action settlement. Kirsh and Hammerand talk about the financials behind the settlem…
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Oct 12, 2023
Boston Scientific's SCS system nabs new FDA approval, Medtech Innovator names Grand Prize winner
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 12, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Novo Nordisk has announced that it acquired all shares of drug delivery device maker Biocorp. Fast Five host Danielle Kirsh and guest cohost Jim Hammerand discuss the deal, including when the acquisition talks began.
Ambu named its new chief financial officer for 2024. Find out who is taking over and what some of their career history is that supports this appointment.
The FDA has approved a next-gen intrathecal drug delivery system from Medtronic. Kirsh and Hammerand talk about the technology and what sets it apart from previous iterations of the device.
Medtech Innovator announced the 2023 Grand Prize winner at AdvaMed's Medtech Conference in Anaheim. Hear who the winner is and wha…
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Oct 11, 2023
Haemonetics makes a $253M acquisition, Boston Scientific to open first factory in China
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 11, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
Hyperfine received FDA 510(k) clearance for its artificial intelligence software for improve image quality on its Swoop portable MRI system. Fast Five host Danielle Kirsh and guest host Jim Hammerand discuss the latest software development and how it updates that MRI system.
Medtronic is warning on some of its previous software on some MiniMed 780G devices in Germany. Find out what the issue is and how patients could be affected.
The FDA wants more testing from Philips in the ongoing recall of its Respironics respiratory devices. Kirsh and Hammerand talk about why the FDA wants more testing from Philips and what Philips plans to do to address that.
Reuters is reporting that Boston Scienti…
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Oct 6, 2023
Precision Neuroscience's BCI wins FDA breakthrough nod
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 6, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Nuro this week announced it achieved communication with a locked-in patient with its neurotechnology. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the technology and what allows the patient to communicate.
Biotronik published positive data for its spinal cord stimulation technology. Whooley explains the technology and what some of the most important data points were from the study.
Dexcom has launched its next-generation G7 continuous glucose monitor in Canada. Hear when the device is slated to hit the market, who it's designed for and what executives think about the launch.
Medtronic appointed a new president of neuromodulation this week. Find out who is taking over this r…
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Oct 5, 2023
Medtronic says some defective video laryngoscopes were stolen and offered for sale illegally
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 5, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Surgical robotics are in the news again today. This time, Microsure announced it raised $40 million to advance its microsurgical robot. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the robot does and what the financing means for the company.
Organ transportation developer Paragonix is expanding its headquarters and has opened its new one in Waltham, Massachusetts. Hear what the expansion reflects for the company and what the new HQ will have.
Butterfly and Razom are expanding their existing partnership to bring more handheld ultrasound systems to Ukraine. Whooley explains the strengths each company brings to the partnership and what they hope to achieve.
Insulet's chief f…
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Oct 4, 2023
Private equity firm reportedly in talks to buy Medtronic business units
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 4, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Akura Medical this week announced that it raised $35 million for its thrombectomy system. Fast Five hosts Danielle Kirsh and Sean Whooley discuss what the technology does and what the company plans to do with the proceeds.
Phillips-Medisize and GlucoModicum are partnering up to create a needle-free continuous glucose monitor. Hear what the primary goal of the partnership is, how the companies plan to achieve that goal and what opportunities each company brings to the partnership.
Augmedics has appointed a former Medtronic artificial intelligence expert as its VP of research & development. Whooley details who joins the company and what some of their career history is.
Baxter also appo…
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Oct 3, 2023
Cordis acquires MedAlliance for more than $1B, SmileDirectClub files Chapter 11
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 3, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
The FDA this week approved Enable Injections' wearable injector. Fast Five hosts Sean Whooley and Danielle Kirsh share what the wearable injector does and what executives are saying about the approval.
Boston Scientific announced the launch of its next-generation insertable cardiac monitor. Find out what this next-gen system does, who some of the key players in the ICM space are and more in today's episode.
Pulse Biosciences and CardioNXT are partnering up to initiate a pulsed-field ablation trial. Whooley details what the goal of the collaboration is and how the two companies plan to achieve it.
SmileDirectClub has filed for Chapter 11 bankruptcy protection and announced plans to recapi…
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Sep 29, 2023
Abbott says GLP-1s could boost CGM use, new report claims Philips withheld CPAP problems from FDA
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 29, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
Inspira is set to unveil its new line of cardio-pulmonary bypass devices soon. Fast Five hosts Sean Whooley and Danielle Kirsh discuss which devices it is planning to unveil and what they do.
Satio was awarded a $3.5 million contract to develop at-home transdermal drug delivery devices. Hear more about what the transdermal device is and what the contract will allow the company to do.
The FDA has granted an investigational device exemption to EnCompass for its cerebral embolic protection system in TAVR procedures. Whooley explains how the device works and what some of the use data with the device has shown.
A new ProPublica and Pittsburgh Post-Gazette report has claimed that Philips re…
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Sep 28, 2023
Edwards Lifesciences facing antitrust scrutiny in Europe, NIH chooses Boston as ARPA-H Catalyst Hub
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 28, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
QT Medical this week announced it raised $12 million in a Series B funding round. Fast Five hosts Sean Whooley and Danielle Kirsh explain what that technology is and how optimistic executives are feeling after the funding round.
BCIs are in the news again this week. This time, Onward announced the first-in-human implant of a stimulator with BCI technology. Whooley details how the technology works with the BCI and what doctors think after the first implant.
Boston Scientific won an FDA nod for its intravascular ultrasound system. Hear how the system works and how it assists clinicians, as well as some of the features that help support clinicians.
The NIH this week chose Boston…
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Sep 27, 2023
ZimVie wins FDA IDE for Mobi-C study, Moon Surgical's first U.S. clinical cases with surgical robot
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 27, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
Senseonics this week announced it completed a 365-day CGM study cohort. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the study evaluated and what were some of the most important results from that study.
iRhythm has launched its next-generation Zio monitor that has enhanced long-term monitoring. Hear some of the details about Zio and the company's launch strategy.
MMI has announced that its surgical robot has surpassed 500 clinical cases. Whooley details the surgical robot, what kind of regulatory backing it has and how some of the procedures went.
Moon Surgical performed its first procedures in the U.S. using its Maestro surgical robot. Find out what procedures it was us…
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Sep 26, 2023
Enovis makes a $840M acquisition, Vicarious Surgical faces NYSE delisting
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 26, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
A new study has backed Attune Medical's esophagus-protecting device. Fast Five hosts Sean Whooley and Danielle Kirsh explain the technology and the regulatory backing behind it.
Surgical robotics are in the news again. USMI is set to debut its Canady surgical robot. Find out what the robot does and what executives are saying.
Dexcom has signed a partnership with RxFood to focus on AI-based nutrition and glucose monitoring for diabetes management. Whooley explains the goal behind the partnership and how they plan to accomplish their goal.
Vicarious Surgical is facing an NYSE delisting. The Fast Five hosts detail what the delisting notice said and what steps Vicarious can take to rectify…
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Sep 22, 2023
Hologic, Bayer partnering for mammography imaging, Medtronic wins CE mark for next-gen CGM
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 22, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
There are more funding raises in the news this week. The first one is from MedTrace, which raised $19 million for its PET-boosting technology. Fast Five hosts Sean Whooley and Danielle Kirsh go over what the funding will go toward and the technology they're developing.
ProSomnus is raising $10 million for its CPAP alternative. Find out what the technology is and how optimistic executives are about the future of the technology.
Whooley details a regulatory nod for Quantum Surgical's surgical robot in China. Hear about what the robot does, what kind of treatment it offers and what executives think about the regulatory nod.
Medtronic Diabetes is having a good year – its Simplera CGM in I…
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Sep 21, 2023
Boston Scientific targets M&A to reach ‘next level’, EU sees potential antitrust activity in medtech
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 21, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
Today's news covers Orthofix's launch of its new fixation system and the first cases with the device were performed. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the system offers to patients and surgeons.
There is also more brain-computer interface (BCI) news this week from Neuralink, which has opened recruitment for its first-in-human BCI trial. Hear more about the study's details and the path Neuralink took to get to this point.
Surgical robots are dominating the news this week. This time, CMR Surgical brought in $165 million in a funding round to support its surgical robot. Learn about the robot and what the funds will be used for in today's episode.
The European…
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Sep 20, 2023
Boston Scientific makes a $850M acquisition, InBrain Neuroelectronics wins FDA breakthrough nod
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 20, 2023.
Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
Virtual Incision this week added $30 million in funding for its miniaturized surgical robot. Fast Five hosts Sean Whooley and Danielle Kirsh explain the technology behind the robot and what the company plans to do with the proceeds from the funding round.
Moon Surgical picked up CE mark approval this week for its updated Maestro surgical robot. Find out what the surgical robot does and how optimistic executives are about the future of the company.
The FDA has granted investigational device exemption to Orchestra BioMed for its cardiac neuromod trial in pacemaker patients. Whooley explains what device is being studied and what the clinical trial will evaluate.
InBrain Neuroelectronic w…
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Sep 19, 2023
Motif Neurotech implants first mini brain pacemaker, Gates Foundation backs GEHC AI-based ultrasound
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 19, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
JenaValve recently announced that a Johnson & Johnson veteran is joining its board of directors. Fast Five hosts Sean Whooley and Danielle Kirsh discuss who is joining the board and some of their career history.
The founder behind Farapulse has closed a $14 million funding round for their new ablation technology company, Field Medical. Find out what the technology is and what the CEO sees for the future of the company.
Inogen has completed its previously announced acquisition of Physio-Assist. Whooley explains how this acquisition plays into Inogen's long-term goals and how it supplements the company's existing portfolio.
The Gates Foundation has given GE HealthCare a grant to support A…
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Sep 15, 2023
Johnson & Johnson retires 136-year old logo, Abbott recalls some IPGs
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 15, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
GE HealthCare is entering another collaboration, this time with the Mayo Clinic for medical imaging and theranostics. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the details behind the collaboration.
Attune Medical this week received FDA authorization to use its ensoETM device in radiofrequency ablation procedures. Find out what the device is and the optimism that executives have.
Ambu's therapeutic gastroscope won CE mark approval this week. Whooley explains what the gastroscope is and some of its features.
Abbott is recalling some of its neurostimulation implants because of an issue involving a Bluetooth bricking flaw. Hear how many devices are affects and if there hav…
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Sep 14, 2023
Akili reduces workforce by 40% as it looks to move to non-prescription model
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 14, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
Aurora Spine this week launched its SiLO TFX MIS sacroiliac joint fixation system. Fast Five hosts Sean Whooley and Danielle Kirsh explain the system's design and when ti received regulatory nods.
Wearables are in the news today. Awak raised $20 million in a Series B funding round for its wearable dialysis device. Hear how the wearable technology works and what the company plans to use proceeds for.
Vaxess also raised money this week for a shelf-stable vaccine patch. Whooley explains the design of the patch and some of the well-known pharmaceutical companies that have shown interest in using the patch.
Samsung's spinoff Wellysis won an FDA nod for its wearable ECG this week. Find out wh…
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Sep 13, 2023
Orthofix fires CEO and others with cause, Bausch+Lomb launches $1.4B offering
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 13, 2023.
Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.
Procept BioRobotics this week won an FDA investigational device exemption (IDE) for its Aquablation prostate cancer therapy. Fast Five hosts Danielle Kirsh and Sean Whooley explain what the therapy is and what the company's plans are for the IDE.
The FDA has approved LimFlow's chronic limb-threatening ischemia (CLTI) treatment device. The approval enables the treatment to help those with CLTI with no other suitable endovascular or surgical treatment options available. Whooley dives into the device design in this episode.
Shockwave Medical is appointing a former Abbott Vascular executive as its chief medical officer. Find out who's taking on this role and what their career history is.
Ba…
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Sep 12, 2023
Analysts think GLP-1 drugs will have minor impact on insulin pump market and boost CGMs
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 12, 2023.
[Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast.]
Zeta Surgical recently announced it won FDA clearance for its mixed reality cranial surgical navigation system. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the navigation system is and how it assists surgeons.
Centinel Spine announced last week that it is divesting its spine fusion business. Find out what the sale means for the company, when the deal will close and what executives think about this strategic move.
Surgical robotics are in the news again. Quantum Surgical won CE mark approval for its surgical robot that treats lung tumors. Whooley explains the purpose of the robot and what the expanded approval follows.
Philips has launched a new ultrasound technology t…
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Sep 8, 2023
Philips reaches settlement in class-action suit, FDA approves Boston Scientific's Watchman FLX Pro
Asensus Surgical wants to incorporate artificial intelligence in its surgical robotic platforms and has partnered with Nvidia. Fast Five hosts Sean Whooley and Danielle Kirsh explain the goal of the partnership and how Asensus plans to use Nvidia's tools.
Align Technology this week launched its Invisalign palatal expanders. Find out what features are included in the palatal expanders and how they differ from gold standard methods.
Inogen's CFO is stepping away from the company and the company named an interim replacement. Tune in to hear who is taking that interim spot and their career background.
Boston Scientific's series of positive news continues this week with the FDA approval of its next-gen Watchman FLX Pro. Whooley describes what the Watchman FLX Pro does and the prevalence use in previous iterations of the device.
Philips has announced that it reached a settlement in the class-action lawsuit stemming from its Respironics sleep apnea machine recalls. Hear what the agr…
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Sep 7, 2023
Abbott to acquire Bigfoot Biomedical, Zimmer Biomet makes handful of executive changes
Admetsys this week won FDA breakthrough designation for its automated glucose control technology. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the glucose control system does and what executives are saying.
Moximed has implanted its first Misha knee implantable shock absorber in the U.S. Find out what an implantable shock absorber is and what doctors think about it.
GE HealthCare and Mass General are collaborating on AI algorithms to predict missed care opportunities, expanding on its existing 10-year partnership. Whooley explains the aim of the collaboration and what the artificial intelligence algorithms will be used for.
Zimmer Biomet announced several executive appointments just days after former CEO Bryan Hanson left. Tune in to discover who joins the executive team and what the new CEO says about the shuffling.
Another diabetes acquisition is in the news – this time, Abbott is acquiring Bigfoot Biomedical. The acquisition follows an established partne…
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Sep 6, 2023
Illumina picks new CEO amid SEC investigation, Synchron completes patient enrollment in BCI trial
Axogen this week announced it launched its AxoGuard HA+ nerve protector. Fast Five hosts Sean Whooley and Danielle Kirsh share details on what AxoGuard is and why it is essential from a doctor's perspective.
The surgical robotics space is expanding. Ronovo Surgical announced it raised $26 million in capital for its surgical robotic platform. Whooley explains what the surgical robot is designed for, what it gives surgeons and what Ronovo Surgical plans to do with the raised capital.
Restor3d's acquisition of Conformis is finalized. Kirsh and Whooley discuss some of the deal's financial details and what executives think about the value-add.
Another trending space in medtech is brain-computer interfaces. Synchron announced this week that it completed patient enrollment in its new BCI trial. Find out the details of the trial, including the study's primary goal, and who are some of the other major players in the BCI space.
Illumina has appointed a new CEO amid its SEC investigation. W…
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Sep 1, 2023
Noah Medical touts first-in-human surgical robot data, Beta Bionics raises $100M for bionic pancreas
Glucotrack is back in this news, this time with news of a former Medtronic veteran being tapped for its board director spot. Fast Five hosts Sean Whooley and Danielle Kirsh go over the new appointee and their career history.
Zeiss Medical Technology this week announced it intends to unveil new ophthalmic innovations within its cataract and corneal refractive workflows. Find out what updates the company is planning to make and what executives are thinking.
LivaNova has received FDA 510(k) clearance for its Essenz in-line blood monitor. Whooley talks about what the blood monitor does, how it helps patients and why this is an important innovation.
Beta Bionics closed a $100 million Series D funding round for its bionic pancreas. Tune in to discover what a bionic pancreas does and how optimistic executives are after this funding round.
The field of surgical robotics is constantly innovating. Noah Medical this week announced positive first-in-human data for its own surgical robot. Lea…
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Aug 31, 2023
3M's $6B earplug settlement, Myomo closes $4.4M public offering
Aion Biosystems announced this week that it won FDA 510(k) clearance for its iTempShield device and software system. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the system is, how it works and what executives are saying about the FDA clearance.
Over-the-counter Narcan just became available with Emergent BioSolutions' recent launch. Find out about the company's FDA approval to get to this point and how it will become available to consumers.
Myomo has closed a $4.4 million public offering. In today's episode, Whooley details the offering and what the company plans to use proceeds for, including potentially expanding its employee count.
Cardinal Health has launched its next-generation neonatal feeding device to reduce NICU stays. Discover how the system works, how it helps clinicians and what executives are saying about the launch.
The legal proceeding with 3M and its combat earplugs has reached a $6 billion settlement. Whooley and Kirsh go over the breakdown of the…
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Aug 30, 2023
Biotronik implants next-gen pacemaker, PolyVascular and CobiCure partner for pediatric heart valves
Implantable continuous glucose maker Glucotrack announced it has a new VP of marketing. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the new VP and their career history that supports the appointment.
Haemonetics is expanding its global presence by launching its vascular closure device in Europe. Find out which device is going global, how it works and what's next for Haemonetics.
The FDA granted 510(k) clearance to ICU Medical's infusion pump and software. Whooley explains what the they do and some of the features that make patient monitoring seamless.
Pediatric devices is an underserved market, and PolyVascular and CobiCure are looking to fix that with a new partnership for non-surgical pediatric heart valves. Hear more about the partnership and what kinds of resources and funding the companies have.
Biotronik has implanted its next-gen pacemaker in its first patients. Whooley details what the Anmia Edge is designed for, what benefits it offers and what doctors think…
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Aug 29, 2023
Rapid adoption expected of Boston Scientific's Farapulse, Medtronic ICDs have life-saving potential
SmileDirectClub and Align Technology are in a legal proceeding from a previous partnership. Fast Five hosts Sean Whooley and Danielle Kirsh discuss SDC's plans to appeal a court order that said it has to pay Align Technology $63 million. In today's episode, find out more about the proceeding and the SmileDirectClub's appeal.
GE Healthcare has unveiled its latest wireless, handheld ultrasound device. Whooley explains what the device does, how accompanying digital tools help clinicians and what executives think about this unveiling.
Diabetes news and continuous glucose monitors continue to innovate. This week, Insulet launched its Omnipod 5 in Germany and announced when it expects a full European launch. Whooley outlines the regulatory pathway Omnipod 5 took to get to the Germany launch and how patients and executives feel about its entry into Europe.
This week, we have study data from the European Society of Cardiology (ESC) in Amsterdam. Medtronic posted study results that demonst…
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Aug 25, 2023
Medtronic's major renal denervation setback, Paragonix's lung preservation system wins FDA nod
This week, the FDA granted a fast-track designation for Nectero Medical's end-vascular aneurysm stabilization treatment system. Fast Five hosts Sean Whooley and Danielle Kirsh explain how the system works and what executives say about this FDA win.
There's more AFib news on the horizon, this time from GE Healthcare. The company launched its CardioVisio digital tool for helping to treat AFib. Find out what the system does and the ultimate goal for GE Healthcare.
SPAC mergers are back in the news as Sanuwave Health plans to go public after a business combination agreement with SEP Acquisition Corp. The proposed transaction is valued at $127.5 million. Hear more about the financial details of the deal and the optimism that executives have.
Long-term organ preservation is important for organ transplants. Paragonix's next-generation BAROguard donor lung preservation system won FDA clearance this week. Whooley explains how the system works and what differentiates it from gold-standard org…
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Aug 24, 2023
Recor Medical's renal denervation system wins FDA panel nod, J&J finalizes Kenvue split off
Masimo this week announced the launch of its Stork home baby monitoring system. Fast Five hosts Sean Whooley and Danielle Kirsh explain how the system works and how it fits in with the flagship products already with the company.
Home hemodialysis is on the rise. Fresenius Medical Care recently received FDA 510(k) clearance for its Versi HD with GuideMe software for its chronic home hemodialysis system. Find out when the technology will become available and how executives envision it for use in the home in today's episode.
Diabetes care devices are consistently innovating, and Welldoc's continuous glucose monitoring is having an exceptional month. Just a week after it received its tenth FDA clearance, Welldoc has received its 11th FDA clearance for its BlueStar digital diabetes management platform. Whooley details what makes this clearance unique and what the clearance allows the company to do.
Johnson & Johnson is placing more focus on its MedTech and Pharmaceutical division by spli…
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Aug 23, 2023
Zimmer Biomet CEO leaves for another medtech company, Medtronic's Q1 results
Medtronic's first-quarter results are in, and they were ahead of the consensus forecast on Wall Street. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the company's performance, what contributed to its growth and how each segment performed.
Wenzel Spine has received FDA clearance for expanded indications of its primaLOK SP system for spinal fusion procedures. Hear how the system works, what some of the features are and what doctors think about using the device.
Surgical robotics continue to innovate in medtech as Levita Magnetics won FDA clearance for its magnetic-assisted robot. Tune in to discover how the minimally invasive surgical platform works and how surgeons can benefit from using it.
Philips issued an urgent field safety notice for some of its imaging systems due to an issue that could lead to unintended radiation. Whooley shares the details of the issue, which systems are affected and what potential outcomes could arise if not addressed.
Personnel changes within…
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Aug 22, 2023
Executive changes at Tandem and Axonics, another recall for Abiomed's Impella
Anika Therapeutics received the final FDA 510(k) clearance for its Integrity implant system for improving outcomes in rotator cuff repair procedures through biologic healing. The hyaluronic acid-based patch augments an injured tendon, promoting rotator cuff healing. Fast Five hosts Sean Whooley and Danielle Kirsh delve into how the device works and what the regulatory nod means for Anika.
Ventricular assist devices save lives and another one may soon be entering the fold. MagAssist won FDA breakthrough device designation for its NyokAssist VAD, which provides mechanical circulatory support for high-risk percutaneous interventions. Find out what led the agency to grant this designation.
Axonics will soon have a new chief financial officer after longtime executive Dan Dearen notified the company of his intent to retire. The company already picked a replacement, promoting from within to fill the role. Learn more about Axonics' selection and what the new executive brings to the company i…
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Aug 18, 2023
ICU Medical to close a facility and cut jobs, TransMedics completes Summit Aviation buy
Nemaura Medical received regulatory approval in the Middle East for its sugarBEAT sensor for glucose monitoring. The regulatory win comes after it received a provisional purchase order for more than 1 million sensors and thousands of devices. Fast Five hosts Sean Whooley and Danielle Kirsh go over what the sugarBEAT sensor is and some of the other regulatory agencies the company is hoping to gain approval from soon.
BlueWind Medical recently won an FDA do novo nod for its Review neuromodulation system. Revi treats symptoms of incontinence. Learn about the device's design and what doctors think about its use in today's episode.
ZimVie wants to focus on diversifying its spine and trauma navigation technologies – and it plans to do that through its recently expanded development deal with Brainlab. Whooley shares the details of what the entire goal of the deal is and what executives are saying.
TransMedics recently completed the acquisition of Summit Aviation. This isn't the typical m…
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Aug 17, 2023
Medtronic's third recall of some hemodialysis catheters, data backs Nevro's spinal cord stim
CathVision this week announced the FDA clearance of its PVI Analyzer and Signal Complexity algorithms for facilitating electrogram interpretation. The regulatory nod makes these artificial intelligence-based tools available to physicians. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the algorithms are used for and what sets them apart from traditional EP recording systems.
AngioDynamics received FDA breakthrough designation for its AngioVac system. The designation includes proposed indications for the use of AngioVac in the non-surgical removal of vegetation from the right heart. Find out what the company plans to do with the breakthrough nod and what executives see for the future of AngioVac.
Tivic Health is planning to begin its vagus nerve stimulation trial after receiving Institutional Review Board (IRB) approval. Whooley shares details of the study, what the IRB approval means for Tivic and what the company hopes to achieve in the study.
New data from a two-year…
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Aug 16, 2023
Philips has another serious recall, Microbot Medical inks surgical robot manufacturing deal
People living with diabetes are always looking for ways to make the management of their chronic condition easier. Welldoc aims to address that with its BlueStar platform, which just received its 10th FDA clearance, this time for using connected insulin dosing data in personalized bolus insulin dosing recommendations. Fast Five hosts Sean Whooley and Danielle Kirsh break down what BlueStar does and how this latest regulatory nod boosts Welldoc.
The episode also covers FDA authorization for another innovative technology — Viz.ai's artificial intelligence-based module for detecting hypertrophic cardiomyopathy. The FDA's de novo nod creates a new regulatory category for cardiovascular machine learning-based notification software. Learn about how this module works as another AI-based technology garners regulatory approval.
Meanwhile, Viseon says it began the U.S. commercial rollout and initial clinical use of its MaxView 4K advanced visualization system. The company describes MaxView 4K…
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Aug 15, 2023
Getinge has another Class I recall, Asensus aims for 2025 FDA clearance for Luna surgical robot
Artificial intelligence is making its way through the medtech industry. iCad recently announced plans to integrate Google AI into its ProFound Breast Health Suite for 2D mammography. Fast Five hosts Sean Whooley and Danielle Kirsh go over how the company wants to use AI and the details of its existing partnership with Google.
A new study from Edwards Lifesciences offers potential support for people with hypotension. Results from a study showed that using Acumen HPI may help reduce the duration and severity of intraoperative hypotension in patients having non-cardiac surgery. Hear how the software works and the full results of the study in today's episode.
Siemens Healthineers and SSM Health want to increase health equity in the U.S. Learn how the two firms aim to expand access to high-quality care and aid in training the next generation of healthcare workers and what executives are saying about the collaboration.
Surgical robotics are a hot topic in medtech, and more new systems are…
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Aug 10, 2023
Shockwave Medical to raise $500M, ZimVie has an updated spin implant set to launch this fall
In this episode, Fast Five hosts Sean Whooley and Danielle Kirsh break down some of the second-quarter highlights for Insulet as it continues to report impressive revenue growth. The automated insulin delivery technology developer offered even more optimism for the rest of the year, raising its guidance as sales of the Omnipod system are taking off. There's also promising news on the product side as Insulet recently shared an update on the progress of the Omnipod's integration with a popular continuous glucose monitor.
Meanwhile, Imperative Care has a new organizational structure, breaking up its business arms into four siloed operating units. The stroke care company is now the parent company for units that cover vascular, digital and robotic medical technologies in an effort to connect innovation and provide meaningful outcomes to patients across the entire continuum of care.
There's also more news on the ablation front, as China-based Baird Medical announced the submission of its d…
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Aug 10, 2023
Boston Scientific's cryoablation wins FDA approval, ReWalk Robotics acquires anti-gravity developer
MassDevice remains the place to go if you want the rundown on earnings season in medtech. This episode's coverage includes a discussion of Masimo's second-quarter performance, which included a significant reduction in the company's 2023 sales guidance. Fast Five hosts Sean Whooley and Danielle Kirsh break down what contributed to the results and why Masimo remains optimistic in the face of some adversity.
Elsewhere, more medtech companies are looking to raise awareness of their offerings through clever marketing campaigns. Staar Surgical announced a collaboration with NFL quarterback Will Levis to promote the company's implantable collamer lenses (ICLs). Levis received the ocular implants to enhance his vision ahead of his first season as a professional football player with the Tennessee Titans. Learn more about what these implantable lenses do for people with myopia and beyond.
SS Innovations made the first international sale of its SSi Mantra surgical robotic platform. The robot pr…
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Aug 9, 2023
Elon Musk's Neuralink BCI tech raises $280M, Embecta reports closed-loop insulin delivery progress
Earnings season continues on MassDevice. Acutus Medical posted Street-beating Q2 results and gave an update on when it expects to receive approval for its AcQBlate ablation catheter. Fast Five hosts Sean Whooley and Danielle Kirsh provide details about the pending approval and what contributed to the company's sales growth in the quarter.
Embecta reported progress on its closed-loop insulin delivery technology in its quarterly earnings results. Find out the status update on that system and what the CEO had to say about the company's performance.
HeartBeam announced the appointment of a VP of regulatory affairs. Tune in to today's episode to find out who will take on the role and what some of their career history supports the appointment.
Orchestra BioMed recently won FDA IDE approval, enabling the company to evaluate Virtue SAB, an AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR. Whooley explains the technology and what the study will assess…
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Aug 8, 2023
Stryker launches Mako direct-to-patient marketing campaign, Tivic Health's $1.4M offering
Tivic Health this week announced that it priced a public offering of common stock. The company plans to use the net proceeds for working capital and general corporate purposes. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the offering includes and give details on the upcoming special stockholder meeting.
Masimo's SedLine brain function monitoring could improve brain monitoring during endoscopy, according to a new study. Find out the key details of the study and how it assesses sedation levels during procedures.
The FDA clearance of Abbott's Alinity h-series hematology system represents a significant milestone for the company, as it expands its product portfolio in the hematology diagnostics market. Whooley explains how the system works and its significance in the field of laboratory diagnostics.
Several of Biosense Webster's ablation devices won a new indication from the FDA. Hear which devices received the expanded indication for zero fluoroscopy workflow and ho…
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Aug 4, 2023
Smith+Nephew CFO steps down, Outset Medical pauses shipments for Tablo accessory
Movano is submitting its smart ring for pulse oximetry to the FDA. Fast Five hosts Danielle Kirsh and Sean Whooley discuss the clinical performance of the smart ring and how it could be a competitive differentiator.
Henry Schein is making a homecare play with the acquisition of Shield Healthcare. Henry Schein officials see the move as bolstering the company’s commitment to facilitating a continuum-of-care delivery model. Hear how the acquisition fits into the company's strategic plan and what types of products will be added to Henry Schein's portfolio.
Vicarious Surgical announced that it priced an underwritten public offering worth approximately $45 million in proceeds. Find out what is included in the offering, when it closes and some of Vicarious Surgical's other positive news.
Earnings season continues, and today's earnings story comes with an announcement of an executive shuffle. Smith+Nephew performed better than analyst expectations in the last quarter, but a vital execut…
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Aug 3, 2023
Cooper Cos. abandons $875M acquisition, Siemens Healthineers reports logistics challenges at Varian
Glytec this week unveiled the newest version of its Glucommander insulin dosing software that enables best practice, personalized care. Fast Five hosts Danielle Kirsh and Sean Whooley discuss the update and what it offers in workflow improvements for patients and physicians.
Water vapor ablation could become the latest treatment option for prostate cancer. Francis Medical received FDA breakthrough designation for its water vapor ablation therapy this week. Find out how the technology works and what makes it a minimally invasive option.
SS Innovations is looking to bring its surgical robot to the market as it started the FDA and CE Mark submission process this week. Whooley explains what the surgical robot does and the timelines and expectations for achieving approvals from the regulatory bodies.
News of some outbound logistics challenges holding back revenue at Varian slightly affected Siemens Healthineers' financial performance in Q3. Learn about the challenges and what steps…
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Aug 2, 2023
Baxter has a Class I recall, Integra Lifesciences to resume manufacturing in Boston after hiatus
Earnings season continues in the medical device industry. Hologic posted its Q3 results this week, and it was a mixed bag. Investors and analysts have questions about future margins. Fast Five hosts Sean Whooley and Danielle Kirsh review the company's performance and the analysts' views.
The FDA recently granted expanded indication to Teleflex's QuikClot Control+ hemostatic device. The expanded indication may allow Teleflex to target new clinical applications. Find out what the expanded indication covers, how it increases the device's versatility in treating different patient populations, and what executives say.
Abbott FreeStyle Libre 3 reader is now available and is covered by Medicare. The Fast Five hosts discuss how the FreeStyle Libre 3 reader works and how it pairs with Abbott's latest continuous glucose monitoring sensor. Gain insights into Abbott's pipeline activity and plans for the second half of 2023.
Integra Lifesciences plans to resume manufacturing at its Boston fa…
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Aug 1, 2023
Abbott withdraws Trifecta valves from U.S. market, Augmedics buys Surgalign's digital health assets
The recent collaboration between Henry Schein and Medpod signifies an increased focus on telehealth solutions and the integration of diagnostic technologies. Fast Five hosts Danielle Kirsh and Sean Whooley discuss how the Medpac system serves as a telediagnostic offering and the benefits it offers patients and providers.
Inspire Medical recently appointed a former AppliedVR executive as its chief medical officer. The move highlights the significance of medical leadership in driving strategic decisions. Hear who is taking on the new clinical role and what their career experience is that supports the appointment.
The successful implantation of Anteris Technologies' DurAVR THV in a valve-in-valve procedure showcases a significant milestone in transcatheter heart valve technology for the company. Whooley explains the significance of the implant and what makes it unique compared to other transcatheter aortic heart valves.
Augmedics' strategic acquisition of digital health assets from…
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Jul 28, 2023
Boston Scientific invests $170M to expand operations, Baxter's BPS divestiture faces uncertainty
Philips' collaboration with CoxHealth showcases the growing importance of virtual care solutions in the post-COVID era. Fast Five hosts Danielle Kirsh and Sean Whooley discuss the aim of the collaboration and some of the feedback and reactions from clinical staff about the virtual care delivery program.
Asensus Surgical's $10M offering indicates its efforts to secure financial resources for expanding its surgical robotics technology and bringing its innovative products to a broader market. Find out how Asensus plans to use the funds and what is included in the offering in today's episode.
The positive data for Know Labs' non-invasive glucose monitor highlights ongoing advancements in non-invasive monitoring technologies and their potential to transform diabetes management for patients. Whooley explains what the technology does and some of the key data points from the study.
Baxter this week announced results from its second quarter that fell short of the consensus on Wall Street…
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Jul 27, 2023
Teleflex makes a $600M acquisition, Abbott has a serious recall of its Amplatzer delivery sheath
LivaNova's Q2 performance and increased 2023 guidance indicate the company's ability to adapt to market challenges and capitalize on growth opportunities. The Fast Five hosts discuss the company's financial performance, which segment had the greatest growth and what the CEO had to say about the quarterly earnings.
Olympus recently launched its EasySuite ES-IP system for procedure room visualization and integration in the U.S. Whooley explains some of the features and capabilities of the new system and the benefits of using the platform in medical procedures.
The positive results from the feasibility study of Glucotrack's implantable continuous glucose monitoring (CGM) system showcase the potential of implantable devices to transform diabetes management. Hear the feasibility study results and the key differentiators of the CGM in today's episode.
Teleflex's decision to acquire Palette Life Sciences reflects its strategic focus on expanding its urology product portfolio and enhancing…
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Jul 26, 2023
3M to name CEO for Health Care spinoff, Baxter names its proposed kidney care spinoff
GE HealthCare's strong Q2 performance and raised guidance signal a positive outlook for the company. The standalone GEHC should benefit from a number of underlying growth drivers in the future as well. Fast Five hosts Sean Whooley and Danielle Kirsh explain what factors contributed to the company's growth and how analysts view performance and prospects.
NeuroOne Medical Technologies recently announced it priced an underwritten registered public offering. The proceeds from the offering may accelerate NeuroOne's research and development efforts. Find out the size of the offering and how NeuroOne plans to use the funds in today's episode.
Ra Medical's increasing demand for its noninvasive electrophysiology mapping system signifies the healthcare industry's emphasis on less invasive procedures and patient-centered care. Whooley explains what product line has had increased use and what expansion efforts the company has undertaken to grow.
Baxter this week picked “Vantive” as the…
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Jul 25, 2023
J&J looks to split-off a business unit, Inspire Medical appoints former Medtronic exec
Philips recently announced Q2 results and an update on the ongoing DOJ talks and layoffs. Industry analysts may discuss Philips' forward-looking plans to mitigate order intake volatility and maintain a competitive edge in the medical device market. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the quarterly results and what the current status of the ongoing consent decree.
The launch of Biosense Webster's AFib mapping catheter signifies J&J's commitment to advancing cardiac ablation technologies for atrial fibrillation patients. Hear how the technology works, how it could benefit clinicians and what doctors and executives think about it.
This week, Baxter announced it launched the PerClot absorbable hemostatic powder in the U.S. Whooley shares the technology behind PerClor and how it enhances clinicians' abilities to optimize patient care.
Inspire Medical Systems' selection of a former Medtronic executive as the new chief strategy officer underscores the ongoing talent mob…
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Jul 20, 2023
Abiomed has a Class I TAVR-related recall, Abbott bets on pipeline to build momentum
Abbott has now seen two quarters in a row of double-digit organic sales growth in its underlying business. Now the company is betting on its productive, innovative pipeline to build momentum. Fast Five hosts Sean Whooley and Danielle Kirsh go over the full performance of the company and how each of its segments performed.
Johnson & Johnson MedTech posted revenues of $7.9 billion, marking a 12.9% improvement year-over-year. Learn what the growth drivers were for the MedTech segment and what analyst's think about the second-quarter results.
The initiation of Magnus Medical's neurostim trial marks a significant milestone in the field of mental health treatment, offering hope for patients with treatment-resistant depression. Whooley and Kirsh discuss the company's technology and the potential impact it could have on the treatment of treatment-resistant depression.
MediView XR announced this week that it received FDA 510(k) clearance for its XR90 augmented reality-based visualization…
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Jul 20, 2023
Masimo aims to reduce costs, Ascensia Diabetes Care inks new deal in Canada
Aetna's policy update expanding access to Neuronetics NeuroStar represents a positive step towards increasing patient accessibility to innovative depression treatment options. Fast Five hosts Sean Whooley and Danielle Kirsh explain what NeuroStar is and the policy update that expands access to the technology.
Biostrap announced that it launched its new Kairos wearable device for data visualization of the autonomic nervous system. Such devices can potentially empower individuals to monitor their health metrics in real time. Hear how the technology works and what the company is doing for diagnostics for the nervous system.
Ascensia Diabetes Care's deal to integrate blood glucose monitors in point-of-care testing reflects the importance of seamless data integration in diabetes management. Whooley details the partnership with Avricore Health and what kind of impact it will have on diabetes care delivery.
Teleflex's completion of enrollment in a percutaneous coronary intervention study s…
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Jul 19, 2023
Medtronic has a Class I recall, Endologix completes first procedures using Detour system
The appointment of a former Medtronic executive as CFO of ForSight Robotics brings valuable industry experience and expertise to the company's leadership team. Fast Five hosts Sean Whooley and Danielle Kirsh discuss who was appointed and why the company decided to appoint them.
Philips' enrollment of the first patients in a stroke diagnosis and treatment trial showcases the company's commitment to advancing stroke care and improving patient outcomes through clinical research. Listen to today's episode to find out what the trial will evaluate and what executives think about the trial.
Drug delivery technology developer Eitan Medical announced this week that it appointed Shaul Sharoni as its new chief financial officer. Whooley goes over Sharoni's career background and how his appointment will contribute to the company's growth and long-term success.
The successful completion of the first procedures using Endologix's Detour system marks a significant milestone in the company's U.S.…
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Jul 18, 2023
U.S. hospital begins pediatric program with Asensus surgical robot, Philips to repurchase shares
Tivic Health's successful pricing of a $2.1 million offering reflects investor confidence in the company's innovative medical device solutions. The offering comes just days after the company closed another $1.8 million offering of common stock. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the offer includes and when it will close.
The collaboration between Glaukos and Radius XR signifies the growing adoption of wearable diagnostics in ophthalmology, aiming to improve disease monitoring and personalized patient care. Hear more about the wearable diagnostic platform and the terms of the collaboration agreement.
IR-MED recently announced positive interim results from a clinical study of its PressureSafe noninvasive, handheld optical monitoring device. Whooley gives an inside look at some of the key findings of the study, as well as what the device does.
Philips initiated a repurchasing program to cover certain obligations arising from long-term incentive plans. Lear…
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Jul 14, 2023
BD discloses 8 cybersecurity vulnerabilities with Alaris, Inogen acquires a company
Boston Scientific received FDA approval for image-guided programming software, advancing deep brain stimulation treatments for neurological conditions. Fast Five hosts Sean Whooley and Danielle Kirsh review what the software offers clinicians.
Henry Schein recently secured a $750 million credit facility, fueling its growth and ability to provide quality products and services in the medical device industry. Learn about the credit facility's maturity, what executives are saying, and some of the busy strategic moves the company made earlier this week.
Aerin Medical's treatment for nasal airway obstruction gained support with data validation, offering effective solutions for improved breathing and quality of life. Whooley and Kirsh discuss what VivAer is and some of the key data points from the study and what doctors think of the device.
Inogen recently expanded its respiratory care portfolio by acquiring Physio-Assist, a French developer of airway clearance technology. Hear about Phy…
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Jul 13, 2023
Illumina faces $478M fine over Grail deal, FDA updates guidance on paclitaxel-coated devices
Olympus this week announced positive study data for its minimally invasive iTind treatment for enlarged prostate symptoms. Fast Five hosts Sean Whooley and Danielle Kirsh go over what that treatment option is, how it works and what some of the study results showed.
Eitan Medical's launch of a cloud-based infusion management platform reflects the integration of digital technologies into healthcare, aiming to enhance patient safety and optimize medication administration. Learn more about what Eitan Insights is and what the company designed the technology for in today's episode.
Urotronic designed Optilume as a minimally invasive surgical therapy to alleviate urinary symptoms caused by BPH – and the FDA approved its use this week. Whooley explains what the technology does and how optimistic executives are after news of the approval.
FDA's updated guidance on paclitaxel-coated devices provides important insights into the ongoing evaluation and monitoring of device safety. Hear a…
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Jul 12, 2023
J&J's Ethicon has a serious electrode recall, Stryker launches cranial guidance software
Heart failure is a prevalent condition that requires effective management and monitoring to improve patient outcomes and quality of life. Shifamed portfolio company Adona Medical recently introduced its next-generation heart failure platform. Fast Five hosts Sean Whooley and Danielle Kirsh detail the technology that is featured in the system and how it works to enhance patient care.
The FDA clearance of Tandem Diabetes Care's Mobi durable automated insulin pump reflects the ongoing advancements in diabetes management and the integration of technology into treatment options. Learn how Tandem's new technology differs from its existing platforms and how it stacks up against other competitors already on the market.
Stryker announced this week that it launched its Q Guidance System with cranial guidance software. This launch comes on the heels of last week’s Ortho Q fully autonomous guidance system launch. In today's episode, Whooley explains what the system is designed for and some…
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Jul 11, 2023
Outset Medical receives FDA warning letter, FTC critiques Medtronic in antitrust case
The FDA clearance of Getinge's non-invasive mechanical ventilator showcases the ongoing efforts to develop advanced respiratory devices that can provide critical support to patients in need. Fast Five hosts Sean Whooley and Danielle Kirsh detail what the ventilator does and when patients can expect the ventilators to hit the market.
PainTEQ's successful fundraising round will expand the commercialization of its LinQ implantable sacroiliac (SI) joint stabilization system. Whooley explains the technology behind the device and the company's success in previous procedures using the device.
Chief financial officers play a crucial role in driving financial strategies, ensuring regulatory compliance, and supporting business growth and sustainability, and Fresenius Medical Care appointed a new one to its executive team. Hear how the appointee's career history supports their appointment and how optimistic executives are in today's episode.
The U.S. Federal Trade Commission wants to have a…
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Jun 30, 2023
NeuroPace CEO resigns, former Depuy Synthes sales rep accused of defrauding hospital
Microbot Medical's completion of a pre-clinical study for its endovascular surgical robot signifies a significant milestone for the company. Fast Five hosts Danielle Kirsh and Sean Whooley explain what the surgical robot does and what the outcome of the pre-clinical study was.
The FDA clearance of Boston Scientific's Embold Soft & Packing coils demonstrates the company's commitment to expanding its portfolio of innovative solutions for embolization procedures. Hear about what the coils are designed for and how it streamlines hospital workflows on today's episode.
Integra Lifesciences' completion of enrollment in the DuraSorb monofilament mesh IDE study is a significant step toward gathering valuable clinical data for this product. Whooley details what the study will evaluate and how optimistic are executives at the company.
Federal prosecutors claim a former DePuy Synthes sales representative defrauded an undisclosed Boston area hospital, with hundreds of thousands of dollars worth…
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Jun 29, 2023
Masimo loses board seats to activist investor, Medline names new CEO
A study demonstrating the health equity impact of Virta Health's diabetes reversal platform highlights the potential of digital health solutions in addressing disparities in healthcare outcomes. Fast Five hosts Sean Whooley and Danielle Kirsh go over the critical points of the study and who the company found is most affected by diabetes.
BioSig's expansion of research and development efforts in machine learning and artificial intelligence (AI) for cardiac arrhythmia treatment signifies the growing role of AI in improving patient care. Whooley details what the company plans to use AI for and how optimistic executives are.
Medline recently announced that it is promoting from within to fill the CEO and president positions opening up at the privately-held medtech giant. Hear who is taking over the corner office and how this transition could be crucial in shaping the company's future.
Carthera's successful Series B funding round, raising $40M, underscores the growing interest and inves…
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Jun 28, 2023
Teleflex has a Class I recall, Boston Scientific appoints two new board directors
Sernova's positive interim data for the Cell Pouch System highlights the potential of regenerative medicine in addressing various medical conditions. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the key findings in the data in today's episode.
Ultra-low frequency neuromodulation has the potential to revolutionize the field by offering more precise and targeted treatment options. Presidio Medical recently raised $72 million for its ultra-low frequency neuromodulation, and Whooley has all the details on the fundraising.
Augmedics' successful funding round and milestone of treating 4,000 U.S. patients with Xvision underscore the growing adoption and impact of augmented reality (AR) in surgical procedures. Hear how the Xvision technology works and why this was a significant capital raise.
Teleflex issued a Class I recall of its Arrow Endurance extended dwell peripheral catheter system. The Fast Five hosts provide more details about how many devices are affected and how many c…
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Jun 27, 2023
Conformis to be acquired by Restor3d, Medtronic appoints new board director
Continuous glucose monitoring (CGM) systems have revolutionized diabetes management by providing real-time data on glucose levels, and new data supports the safety and accuracy of Senseonics 365-day CGM. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the study's key findings.
Aortic aneurysms pose significant health risks. The FDA's approval of Cook Medical's endovascular graft trial represents a positive development in treating this condition. Hear how Cook Medical wants to make the gold-standard treatment of aortic aneurysms easier.
Diabetes management is not limited to insulin users alone, and Dexcom's endeavor to develop a glucose sensor for non-insulin users reflects a commitment to inclusivity. Whooley explains what the technology will cover and how Medicare will cover the innovation.
Medtronic's appointment of Greg Lewis as director adds another seasoned professional with extensive financial experience to the company's leadership team. The Fast Five hosts detail hi…
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Jun 23, 2023
Integra Lifesciences names new CFO, Teleflex recalls Rüsch endotracheal tubes
Teleflex's voluntary recall of its Rüsch endotracheal tubes highlights the possibility of oxygen desaturation, and in the event, any immediate or long-term health consequences depend on the degree and duration of desaturation. Fast Five hosts Sean Whooley and Danielle Kirsh share what issue caused the recall and how many complaints the company has received so far.
The FDA's IDE approval of Metavention's renal denervation therapy represents an important milestone in the treatment of hypertension. Whooley details what the platform does, how it works and how optimistic executives are.
Real-world data validating the efficacy and usability of Bigfoot Biomedical's diabetes management platform underscores its potential to revolutionize diabetes care. Kirsh and Whooley discuss some of the key data points from the study and the company's future plans.
Insulet's ongoing efforts to integrate its Omnipod 5 system with Abbott's FreeStyle Libre 2 sensor marks a significant advancement in the com…
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Jun 22, 2023
Surgalign files Chapter 11 to sell some businesses, GE Healthcare & Depuy Synthes partner up
The availability of Insulet's Omnipod 5 automated insulin delivery system in the UK is a significant development in diabetes management. Fast Five hosts Sean Whooley and Danielle Kirsh explain the system's impact on people with diabetes in the regions where it is already available and where the company plans to launch next.
Teleflex's partnership with Insighters Medical to distribute Insighters' video laryngoscope is an exciting development in airway management. Whooley provides the details of the partnership and what Insighters technology does for patients and providers.
A new partnership between GE Healthcare and DePuy Synthes allows GE HealthCare's imaging technologies and DePuy Synthes' orthopedic solutions, aiming to optimize surgical planning and improve the accuracy of spinal procedures. The Fast Five hosts discuss the technology being shared and how this partnership complements GE Healthcare's ongoing partnerships.
The partnership between Philips and Biotronik signifies a…
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Jun 21, 2023
BD sells surgical instrumentation assets, CorWave raises $64M to manufacture LVADs
The partnership between Nuwellis and DaVita to launch an ultrafiltration therapy pilot program is an exciting development in the field of renal care. The agreement enables Nuwellis — formerly CHF Solutions — to pilot its Aquadex ultrafiltration therapy within selected U.S. markets. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the partnership in detail and what executives say about it.
CorWave's successful fundraising of $64 million is a significant milestone for the company as it prepares to manufacture its left ventricular assist device (LVAD). LVADs play a critical role in supporting patients with advanced heart failure, and CorWave's technology has the potential to improve patient outcomes and enhance their quality of life. Learn more about the company's technology and other developments in today's episode.
Avanos Medical's decision to acquire Diros Technology is a strategic move demonstrating the company's commitment to expanding its portfolio and addressing unmet…
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Jun 16, 2023
Siemens Healthineers lays off workers, Philips warns on Allura, Azurion systems
The release of positive 2-year data supporting the Endologix Detour system is significant news in the field of peripheral arterial disease (PAD) treatment. This data provides strong evidence of the system's long-term efficacy and durability in managing PAD, a condition that affects a significant number of individuals globally. Fast Five hosts Sean Whooley and Danielle Kirsh explore the data behind the study.
Relievant Medsystems' positive data highlights the potential of nerve ablation as a minimally invasive and effective approach to pain management. By targeting specific nerves responsible for transmitting pain signals, this procedure may provide lasting pain relief and improve patients' overall quality of life. Whooley details what the device does and the results from the study, including what doctors think about the technology.
The backing of Politan's nominees by Institutional Shareholder Services (ISS) in the ongoing board battle at Masimo is a notable development in the compan…
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Jun 15, 2023
Stat Health unveils in-ear wearable that measures blood flow, Cala launches wearable for Parkinson's
The FDA's approval of a new peripheral arterial disease (PAD) treatment from Endologix marks a significant milestone in addressing this prevalent condition. PAD affects millions of people worldwide, and this approval provides healthcare professionals with an additional treatment option to improve patient outcomes. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the device is and how it works to improve patient outcomes.
Surmodics recently received FDA 510(k) clearance for its Pounce LP thrombectomy system. The company designed Pounce for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. Whooley details the optimism from executives and when the company expects to initiate a limited market evaluation.
The launch of Stat Health's in-ear wearable device that measures blood flow introduces an exciting advancement in remote health monitoring. This innovative wearable technology provides individuals with a convenient and non-invasive mea…
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Jun 14, 2023
Illumina CEO resigns, Medtronic begins shipping MiniMed 780G in the U.S.
Gore's initiation of a study to compare the VBX stent graft with metal stenting highlights their commitment to advancing the field of vascular interventions. This study aims to provide valuable insights into the safety and efficacy of different treatment options, ultimately improving patient outcomes. Fast Five hosts Sean Whooley and Chris Newmarker explain the details of the study, including the primary endpoint and how doctors feel about the device and study.
Bioretec's decision to increase production capacity for bioresorbable implants reflects the growing demand for advanced implant technologies and their potential to revolutionize patient care. Hear how the company expanded production and how the implant impacts patients.
Abbott's recent changes in the executive team, including the appointment of a new CFO, indicate the company's commitment to strategic leadership and its efforts to drive continued growth and innovation. Whooley shares who's out and who's in at the company.
M…
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Jun 13, 2023
Medtronic warns on some Vanta neurostimulators, Dexcom study shows diabetes’ impact on mental health
NeuroOne's submission of its RF ablation system for FDA 510(k) clearance marks a significant step forward in its pursuit of providing advanced treatment options for patients. If granted clearance, this technology could offer healthcare professionals a valuable tool in treating various medical conditions, potentially improving patient care and quality of life. Fast Five hosts Sean Whooley and Danielle Kirsh explain how the technology works.
Neuronetics' recent FDA clearance for its OCD motor threshold (MT) cap technology for NeuroStar advanced therapy for mental health reinforces the importance of continued research and development in the field of mental health. Whooley details the transcranial magnetic stimulation and how optimistic executives at the company are.
The unveiling of Stevanato Group's on-body drug delivery device represents a significant advancement in medication administration for the company. With its programmable micro-precision basal doses and full-content basal in…
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Jun 9, 2023
Avanos Medical sells respiratory health business, ResMed says PAP adherence reduces hospitalizations
Obvius Robotics' successful completion of the first human cases with the Certa access system represents a significant milestone for the company. Obvius Robotics' achievement highlights the ongoing progress in robotic-assisted surgery, where companies strive to develop solutions that improve surgical precision, reduce invasiveness, and minimize patient recovery time. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the technology and what doctors think about the technology.
The study supporting Imperative Care's stroke treatment offers valuable insights into improving patient outcomes in stroke care. By addressing the unique challenges of stroke care, Imperative Care aims to enhance the standard of care and improve patient prognosis. Whooley details the technology and some of the key data points from the study.
The partnership between AliveCor and Luscii to develop a 'heart clinic in a box' represents an exciting advancement in remote cardiac care. This collaboration aims to pr…
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Jun 8, 2023
iRhythm FDA warning letter alleges violations & deaths, Shacey Petrovic joins Imperative Care board
The FDA clearance of Teleflex's Wattson temporary pacing guidewire represents an important milestone in cardiac care for the company. Fast Five hosts Danielle Kirsh and Sean Whooley explain how the technology works and what executives hope to achieve with the device.
Inari Medical's launch of its RevCore and Triever16 Curve catheters marks a significant development in the field of endovascular care. These catheters offer advanced capabilities for the treatment of venous and arterial diseases, providing physicians with enhanced tools for precise and minimally invasive interventions. Whooley details what the catheters do and the reception the devices have had from doctors.
Know Labs' non-invasive glucose monitoring prototype showcases the company's dedication to developing advanced technologies that improve the lives of individuals with diabetes. By offering a non-invasive glucose monitoring option, this device has the potential to enhance patient compliance, simplify self-care rou…
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Jun 7, 2023
Precision Neuroscience begins first-in-human brain-computer interface trial, BD expands in Ireland
The FDA clearance of DeepX Diagnostics' teledermatology screening solution marks a significant advancement in remote dermatological care. This innovative technology allows healthcare professionals to assess and diagnose suspected skin cancer lesions remotely, potentially improving access to timely and accurate dermatological evaluations. Fast Five hosts Sean Whooley and Danielle Kirsh share details about the system and what the company essentially hopes to achieve with the technology.
Avatar Medical designed its VR surgical platform to help surgeons better prepare for procedures through VR representations of patients. Patient “avatars” generate instantly from CT scans or MRIs for use with the VR platform. Whooley outlines the company's latest FDA 510(k) clearance and the prevalence of use among surgeons so far.
Olympus' plan to establish a series of digital centers based on Odin Vision's cloud-AI technology signals a transformative step in endoscopy and medical imaging for the…
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Jun 6, 2023
Abiomed has a Class I recall, Novo Nordisk wants a majority stake in BioCorp
Sparrow BioAcoustics' FDA clearance for their smartphone stethoscope marks a significant advancement in remote patient monitoring and telehealth. This innovative technology allows healthcare professionals to capture and analyze heart and lung sounds using a smartphone, enabling more accessible and convenient monitoring of patients' respiratory health. Fast Five hosts Sean Whooley and Danielle Kirsh have all the details.
The FDA clearance of GE Healthcare's Sonic DL AI technology for expediting MRI scans is another significant breakthrough in medical imaging. This platform could enable new imaging paradigms, including high-quality cardiac MRI in a single heartbeat. Whooley explains how the technology works and what this could mean for cardiac imaging and healthcare.
Masimo's FDA clearance of its vital sign monitor highlights the importance of telehealth in today's healthcare settings. This wearable device provides continuous monitoring of key vital signs, such as heart rate, oxygen sa…
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Jun 2, 2023
Bayer is making a big digital health play, startup Ezra wants to make a 15-minute MRI using AI
The FDA clearance obtained by startup Ezra for its AI technology marks a significant milestone for the company. Ezra wants to reduce MRI times to 15 minutes. Hear more from Fast Five hosts Danielle Kirsh and Chris Newmarker as they outline what the technology does and its potential to streamline MRI scans.
B. Braun recently launched its DoseTrac Enterprise infusion management software for hospital systems. The technology can connect up to 40,000 different infusion pumps at once. Get the details from Newmarker about how the technology helps hospitals reach significant results and how the mobility of the system increases efficiency.
ABK Biomedical's FDA investigational device exemption (IDE) approval for tumor-treating microspheres is a significant development in the field of interventional oncology. This milestone enables ABK Biomedical to conduct clinical trials and gather crucial data on the safety and efficacy of their microsphere technology for the treatment of tumors. Kirsh and N…
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Jun 1, 2023
iRhythm's FDA warning letter, Masimo management and activist investor trade blows
The global release of Exactech's next-generation GPS Shoulder system marks an important milestone in shoulder arthroplasty. The launch, taking place in EMEA and APAC countries, follows the first surgery in the United Arab Emirates earlier this month. Fast Five Hosts Danielle Kirsh and Chris Newmarker share details about the orthopedic device and what doctors think of the system.
With a new CE mark, Establishment Labs has completed a full transition of all currently marketed Motiva implants and tools, as well as the company’s quality management systems, to be in compliance with the new European Medical Device Regulation (MDR). Newmarker explains the devices included in the new indication and what surgeons and executives think about it.
The FDA's breakthrough designation for CardioRenal's Tenor at-home blood potassium measuring device signifies a significant advancement in monitoring and managing blood potassium levels in patients. This innovative device enables individuals to conven…
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May 31, 2023
Titan Medical licenses out all of its IP to Intuitive, a Medtronic exec moves to Baxter
The partnership between HeartBeam and Samsung is a significant development in the field of cardiac care, as it combines HeartBeam's expertise in cardiac services with Samsung's global reach and technological prowess. Fast Five hosts Danielle Kirsh and Chris Newmarker have all the details of the partnership.
Concept Medical's FDA IDE approval for the sirolimus-coated balloon MagicTouch PTA is a significant development in the treatment of superficial femoral artery disease. This approval allows for the investigation of the device's safety and efficacy in treating this condition. Kirsh and Newmarker discuss the approval and the other indications the device has received in recent months.
Think Surgical's FDA clearance of its handheld robotic knee surgery device, the TMINI miniature robotic system, represents a major milestone in the field of orthopedic surgery. This innovative technology assists surgeons in performing total knee surgeries with enhanced precision and control. Newmarker ex…
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May 26, 2023
Medtronic's nearly $740M acquisition, Boston Scientific bows out of an acquisition
Medtronic, as a leading medical device company, plays a significant role in the industry, and its stock performance is closely watched by investors and industry experts. The recent dip in Medtronic's stock can be attributed to the company's growth projections falling short of market expectations. Fast Five hosts Sean Whooley and Danielle Kirsh outline the company's performance in the last quarter and what it anticipates for the future.
HeartBeam's win of an AI-related patent for its handheld vector ECG (electrocardiogram) device highlights the company's commitment to innovation and technological advancements in cardiac care. Whooley explains how the technology works and what's ahead for HeartBeam.
The FDA's approval of Zoll therapy for sleep apnea patients undergoing MRI scans is a significant development in the field of sleep medicine. The approval of Zoll therapy specifically for patients requiring MRI scans ensures that individuals with sleep apnea can undergo necessary imaging pr…
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May 25, 2023
Boston Scientific adds 400 jobs in Ireland, ICU Medical recalls some infusion pump batteries
Artivion has received FDA premarket application approval for its PerClot absorbable hemostatic system, designed to control bleeding in surgical procedures. The approval marks a significant milestone for Artivion, which will now transfer full ownership to Baxter following a sale agreement in July 2021. Fast Five hosts Sean Whooley and Danielle Kirsh give all the details of the transaction and what technology is involved in PerClot.
Stryker has announced that surgeons have initiated early product surveillance cases for its Q Guidance system with cranial guidance software. The system, designed as an image-based planning and intraoperative platform, expands its support to cranial surgeries to enhance workflows for surgeons and improve patient outcomes. Whooley explains how the guidance system works and what surgeons think of the technology so far.
Masimo has announced the global expansion of its HEOS platform, offering always-on connection through its secure cloud. The platform now integ…
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May 24, 2023
Cala Health, Cue Health have layoffs, Noah Surgical's first U.S. procedure using surgical robot
Companies often make strategic decisions to divest non-core businesses to optimize their focus and resources on areas where they have a competitive advantage. Bioventus' recent completion of the wound business divestiture marks a strategic move to streamline its focus and resources on core areas of expertise. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the financial details of the divestiture.
The FDA's approval of another nasal spray for treating opioid overdose represents a positive step in combatting the ongoing opioid crisis. This nasal spray offers a user-friendly, non-invasive method for delivering life-saving medication to individuals experiencing opioid-related emergencies. Whooley details the approval and the optimism FDA Commissioner Robert Califf has.
The successful completion of the first surgical procedure in the U.S. using the Noah Medical surgical robot marks a significant milestone in robotic-assisted surgery. These robots incorporate advanced technologies…
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May 23, 2023
Philips says AI can predict arrhythmia, data backs Medtronic's Harmony transcatheter pulmonary valve
Abbott recently released significant data backing the use of its Aveir dual-chamber leadless pacemaker. This data provides valuable insights into the device's performance, efficacy, and safety. Fast Five hosts Sean Whooley and Danielle Kirsh dive into the details of the study, examining the key findings and their implications for patients who may benefit from this advanced pacemaker technology.
Moving on to Boston Scientific, which has shared positive data on two of its notable devices: Farapulse and Watchman FLX. The data supporting Farapulse demonstrates its potential in treating specific cardiac conditions, and the positive data for Watchman FLX highlights its effectiveness as a left atrial appendage closure device. Whooley explores these findings in detail, discussing how they contribute to the evolving landscape of cardiovascular care.
A recent study from Philips suggests that artificial intelligence could predict ventricular tachycardia or arrhythmia. The study showcases the po…
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May 19, 2023
J&J's Biosense Webster names new president, Paradromics raises $33M for BCI tech
In a significant development, the FDA has cleared Abbott's insertable cardiac monitor, marking an important advancement in cardiac care. This device offers healthcare professionals a valuable tool for long-term monitoring of patients' heart rhythms, enabling early detection and timely intervention. Fast Five hosts Sean Whooley and Danielle Kirsh detail what the device does and how optimistic executives at the company are.
Paradromics has raised $33 million in funding. This substantial investment reflects the growing interest and potential of brain-computer interfaces in revolutionizing how we interact with technology and understand the human brain. Whooley and Kirsh discuss how the technology works and some of the other major players in the space.
The FDA has approved MicroPort's next-generation of pacemakers. Whooley explains what sets these devices apart from previous iterations, what they do and how executives are looking to further advance cardiac rhythm management.
A recent stu…
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May 18, 2023
Precision Lens faces $487M judgment in kickbacks case, Moon Surgical raises $55M for surgical robot
Moon Surgical, a promising player in the field of surgical robotics, has successfully raised $55.4 million in funding to support the development of its surgical robot platform. This significant investment indicates growing confidence in Moon Surgical's technology and its potential to revolutionize surgical procedures. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the company's technology and what those new funds are earmarked for.
In a creative and impactful move, Hologic has partnered with Eagles rookie Kelee Ringo and his mom to raise awareness about the importance of mammograms. This collaboration sheds light on the critical role of regular mammograms in the early detection and prevention of breast cancer. Whooley explains the details of the partnership, as well as the numerous other partnerships Hologic has engaged in to promote women's health and wellness.
An independent study has provided further validation for Edwards' aortic valve with Resilia tissue. The study's…
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May 17, 2023
Philips claims recalled CPAPs unlikely to cause appreciable harm, Cook Medical announces layoffs
Intuitive Surgical, a leader in robotic surgery systems, announced executive changes in its management team this week. Fast Five Hosts Danielle Kirsh and Sean Whooley detail the shake-up at the company, including who was promoted to president and EVP and chief strategy and corporate operations officer. Gary Guthart, who has been CEO since 2010, still remains at the helm.
Promising news in the field of pain management as the FDA approves Abbott's spinal cord stimulation devices for non-surgical back pain. This milestone approval provides a new option for patients suffering from chronic back pain, offering potential relief without the need for invasive surgery. Whooley explains how the technology works and the study data that backs its use.
Smith+Nephew, a global leader in orthopedic technology, has unveiled a pair of AI-powered surgical robotics tools. These tools are designed to assist surgeons in complex procedures, enabling more precise and efficient surgical interventions. Fast Fi…
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May 16, 2023
Medtronic, J&J reportedly eye an acquisition, Onward implants first movement-restoring lead
On today's episode, Fast Five Hosts Danielle Kirsh and Sean Whooley discuss new data from Biosense Webster's radiofrequency ablation system. The study results suggest better treatment of atrial fibrillation using the company's QDOT catheter. This breakthrough technology offers promising results for patients suffering from this common heart rhythm disorder, providing new possibilities for more effective treatment options.
BrainsWay has launched a study program aimed at evaluating the effectiveness of its deep transcranial magnetic stimulation (dTMS) technology. The technology is used to treat several neurological and psychiatric conditions, including depression, obsessive-compulsive disorder, and smoking cessation. Whooley gives an inside look at how the technology works and what the company hopes to achieve in the study.
Continuous glucose monitoring maker Dexcom has released new clinical evidence supporting the use of its G6 continuous glucose monitoring (CGM) system in Japan. The…
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May 9, 2023
Join us at DeviceTalks Boston this week
Join the MassDevice Fast Five hosts in person at DeviceTalks Boston May 10-11. DeviceTalks Boston is a conference dedicated to bringing attendees insights from some of the top leaders in the medical device industry. With keynote presentations from CEOs at some of the largest medtech companies in the world and panel discussions from industry experts, you won't want to miss an opportunity to connect with medtech's thought leaders.
Visit devicetalks.com to register and join the MassDevice team at the Boston Convention Center.
We'll be back for our regularly scheduled episodes on Tuesday, May 16. Thank you for listening. In the meantime, read and listen to previous episodes at massdevice.com/podcast.
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May 5, 2023
Stryker faces another bribery investigation, ZimVie cuts 5% of its workforce
Cognixion has been granted a breakthrough device designation by the FDA for its BCI technology – a fast-growing market with few competitors. Fast Five hosts Danielle Kirsh and Sean Whooley discuss how Cognixion's technology could enable those with severe motor impairments to communicate and interact more effectively and independently.
ZimVie's stock continues to soar despite the company announcing a 5% workforce layoff. The move comes after the company reported positive Q1 results, showing strong growth in revenue and net income. Whooley gives listeners the details to know about the layoffs and some of ZimVie's financial figures during Q1.
The recent approval of Medtronic's Guardian 4 CGM sensor in Canada is a significant milestone for Medtronic, as it allows the company to expand its offerings in the Canadian market and provide patients with a more comprehensive diabetes management solution. The Fast Five hosts discuss what the technology does and some of the other regulatory mile…
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May 4, 2023
Enovis acquires external fixation portfolio, LivaNova more than doubles profits
A new study out of the U.K. backed Dexcom's real-time continuous glucose monitoring. The news comes shortly after the company had big wins in the U.S Fast Five hosts Danielle Kirsh and Sean Whooley give an inside look at what the study detailed and what this could mean for people with diabetes in the U.K.
Enovis is continuing to expand its foot and ankle portfolio – this time with a strategic product acquisition. Whooley details the acquisition and how Enovis is supplementing its growing portfolio.
Earnings season in the medical device industry continues. This week, LivaNova reported first-quarter earnings that showed it more than doubled its profits compared to Q1 2022. Kirsh and Whooley discuss the financial details and which LivaNova segments outperform others.
Magenta Medical's recent $55 million funding round will enable the company to accelerate the development and commercialization of its miniature heart pump technology. The successful funding round is a sign of investor…
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May 3, 2023
Masimo, Apple patent spat ends in mistrial, 3M layoffs are happening at HQ
With a focus on innovation and strategic acquisitions, Zimmer Biomet is well-positioned to maintain its leadership position in the orthopedic market. Fast Five hosts Danielle Kirsh and Sean Whooley discuss Zimmer Biomet's first-quarter earnings results this week and how investors reacted.
Dexcom's recently proposed $1 billion offering of convertible senior notes is a sign of the company's commitment to expanding its business and developing new technologies. Whooley gives listeners the financial details of the offering and what it earmarked those funds for.
Stryker's acquisition of Cerus Endovascular is an important step toward expanding its portfolio of neurovascular devices. With the increasing demand for minimally invasive neurosurgery techniques, companies like Stryker are well-positioned to capitalize on this trend and provide innovative solutions for patients. Whooley explains how Cerus Endovascular will expand Stryker's vast portfolio.
The layoffs at 3M, including 1,100 at i…
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May 2, 2023
Medtronic's next-gen leadless pacemakers, Casana's smart toilet seat win FDA nods
Customized orthopedics is a growing trend in the medical device industry. Zimmer Biomet's recent acquisition of Ossis underscores that trend toward personalized medicine. Fast Five hosts Danielle Kirsh and Sean Whooley give an inside look at the acquisition and how it will complement the orthopedic giant's vast portfolio.
Chronic venous insufficiency (CVI) happens when a patient's blood vessels in the lower limbs do not effectively pump blood back to the heart, causing valves in the leg veins to become damaged and less effective. Cook Medical wants to fix that. Whooley details the company's initiation of its venous valve trial and how its device aims to reduce the occurrence of CVI.
Home heart monitoring could get easier with the recent FDA clearance of a smart toilet seat. Hear from the Fast Five hosts how the smart seat works and when potential users can expect to see it on the market.
Continuous glucose monitoring innovations are rapidly gaining regulatory milestones across the g…
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Apr 28, 2023
Diabetes tech scores big win in Canada, 3M's hydromechanical wound dressings get FDA nod
More diabetes wins are in the news this week. Dexcom announced that its G6 continuous glucose monitor won expanded coverage in Canada. Fast Five hosts Sean Whooley and Danielle Kirsh discuss how the indication could expand access to the diabetes management technology to underserved communities.
Innoblative Designs won FDA breakthrough designation this week for its ablation device that is indicated for breast cancer surgery. Whooley details how the device works and how the company anticipates it to streamline procedures and workflows.
It's not your average bandage. Kirsh and Whooley discuss the technology behind 3M's latest Veraflo therapy dressings that recently received FDA clearance. The Fast Five hosts also provide insight from surgeons who are ready to use the dressings.
Spinal cord stimulation could be used to treat diabetes complications – that's what Nevro hopes with its latest PDN Sensory study. Kirsh and Whooley provide more details about the clinical trial and what benef…
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Apr 27, 2023
Medtronic remediates FDA warning letter, Boston Scientific nearly triples profits in Q1
Patients with diabetes rely on certain devices for their daily management, and it is vital that they have confidence in the safety and effectiveness of their products. On today's episode, Hosts Danielle Kirsh and Sean Whooley detail how medtech giant Medtronic resolved its earlier FDA warning letter related to its diabetes business.
GE Healthcare recently launched its next-generation intraoperative ultrasound technology, a significant advancement in medical imaging. Whooley discusses how the technology could streamline physician workflow in the operating room.
Non-invasive biometric monitoring is on the horizon. Fast Five hosts Kirsh and Whooley discuss CardieX's recent FDA clearance and how it could allow healthcare providers to monitor blood pressure and central blood pressure using arterial waveform analysis.
Despite an earnings season full of economic headwinds, Boston Scientific nearly tripled its profits in Q1. This is a positive sign for the medical device industry as it indi…
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Apr 26, 2023
3M lays off thousands of workers, another major insulin pump maker wins FDA nod
Layoffs are becoming a common occurrence in the medical device industry, and they can be a result of various factors. Fast Five hosts Danielle Kirsh and Sean Whooley explore 3M's latest layoff and what the company hopes to do in its restructuring efforts.
Insulin pumps are a crucial medical device for people living with diabetes. Insulet, one of the major diabetes device companies in the industry, recently won FDA clearance for its Omnipod GO. Whooley discusses what that means for diabetes patients and when they can expect to see the device on the market.
Proprio recently won FDA clearance for its orthopedic surgical navigation platform. It is reported that the system is projected to improve orthopedic procedures and help surgeons more accurately place pedicle screws. The Fast Five hosts discuss how the system works and how executives feel about the company's innovations to come.
Life support devices are important for sustaining patients, and the demand for the devices was unprecede…
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Apr 25, 2023
Philips' new recall litigation provisions, Boston Scientific could eye billion-dollar acquisition
More diabetes and robotic surgery innovations are in the news today. The FDA approved Medtronic’s newest iteration of its MiniMed insulin pump. Sean Whooley gives a detailed look at the newest device and what sets it apart from other versions.
Philips has been dealing with a series of recalls related to its Respironics line of devices. This week, the company posted Q1 earnings and announced recall litigation provisions. Hosts Danielle Kirsh and Whooley discuss what that means for the company and what investors have to say about it.
Smith+Nephew is a major player in the robotic-assisted surgery market with its orthopedic offerings. It recently launched a digital tensioning device to supplement its robotic system. Whooley describes the new device and how it fits into Smith+Nephew’s current offerings.
Major innovations are taking place in the neurology space. Axonics, which is working on sacral neuromodulation, recently acquired technology to speed up the placement of implantable l…
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Apr 2, 2023
Trailer: Welcome to the MassDevice medtech news podcast
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology.
In each episode, we’ll bring you daily news and analysis from the world of medical devices, exploring the cutting-edge products and treatments that are revolutionizing healthcare. From innovative diagnostic tools to life-saving implants and beyond, we’ll take a deep dive into the business, science and engineering news that powers these remarkable innovations.
Subscribe to the MassDevice Fast Five and join us every weekday for your daily medtech roundup. Thank you for listening.
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