Medical Devices
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Courtesy of Edwards Lifesciences
CMS proposes Medicare coverage for transcatheter tricuspid replacement
Edwards submitted a request for a national coverage determination in February, after receiving FDA approval for its Evoque device earlier that month.
By Elise Reuter • Dec. 20, 2024 -
Permission granted by CMR Surgical
Robots, AI and PFA: The top medtech Q&As of 2024
From challenging market leaders to the growing influence of artificial intelligence, medical device executives had a lot to discuss this year. Check out MedTech Dive’s top Q&As of 2024.
By Ricky Zipp • Dec. 20, 2024 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Foremniakowski via Getty Images
Heart valve developer Anteris launches IPO
IPOs in medtech have been sparse, but some analysts said improving market conditions could support a revival of offerings in 2025.
By Susan Kelly • Dec. 20, 2024 -
Permission granted by Becton Dickinson
BD receives FDA warning letter over quality system violations
Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety complaints were also listed that BD didn’t report within the required timeframe.
By Nick Paul Taylor • Dec. 20, 2024 -
N/A via Getty Images
Medical device recalls under the spotlight in 2024
Medtech regulators and watchdogs took a closer look at recalls in 2024. Here’s a recap of notable recalls and product safety actions in the past year.
By Elise Reuter • Dec. 19, 2024 -
Courtesy of Boston Scientific
Boston Scientific updates cryoablation catheter instructions after 4 death reports
The update followed a higher than expected number of reports of esophageal injury after catheter ablation procedures for atrial fibrillation.
By Nick Paul Taylor • Dec. 19, 2024 -
Retrieved from Merit Medical on December 17, 2024
Merit Medical president to resign after unspecified conduct allegations
Joseph Wright’s resignation is effective in January, and CEO and founder Fred Lampropoulos has been reappointed president.
By Susan Kelly • Dec. 18, 2024 -
Courtesy of Dexcom
Dexcom adds generative AI to over-the-counter CGMs
Dexcom this week began rolling out the feature, which analyzes data to provide personalized tips and recommendations.
By Elise Reuter • Dec. 18, 2024 -
Justin Sullivan via Getty Images
Trump’s return to office brings uncertainty for medtech industry
With about one month before inauguration day, check out a roundup of MedTech Dive’s coverage on what President-elect Donald Trump’s new administration means for medical device companies.
By Ricky Zipp • Dec. 18, 2024 -
Courtesy of Edwards Lifesciences
Medtech firms have cut thousands of jobs this year. Will layoffs continue in 2025?
Industry experts said profit pressures and M&A contributed to job cuts. They said layoffs will likely continue into next year, but some expect the cuts to slow.
By Elise Reuter • Dec. 18, 2024 -
Courtesy of Boston Scientific
Boston Scientific recalls Accolade pacemakers tied to 2 deaths
Certain Accolade pacemakers can permanently enter safety mode, which limits the devices’ ability to treat patients properly and requires early replacement.
By Ricky Zipp • Dec. 17, 2024 -
Permission granted by Becton Dickinson
BD to pay $175M to settle charges of misleading investors on Alaris pump
BD will pay a civil penalty to resolve charges it misled investors about risks associated with sales of its Alaris infusion pump, the Securities and Exchange Commission said.
By Elise Reuter • Dec. 17, 2024 -
Permission granted by Zimmer Biomet
Zimmer receives FDA nod for stemless shoulder implant
The Osseofit devices are intended to match patients’ shoulder bone anatomy and preserve healthy bone in total shoulder replacement procedures.
By Elise Reuter • Dec. 16, 2024 -
Courtesy of Medtronic
PFA to surpass radiofrequency ablation in 2025: Citi survey
Pulsed field ablation could soon be used in the majority of electrophysiology procedures to treat atrial fibrillation as Medtronic, Boston Scientific and Johnson & Johnson battle for market share.
By Susan Kelly • Dec. 16, 2024 -
Courtesy of Fresenius
FDA issues first early alert with Fresenius Kabi infusion pump recall
Fresenius Kabi is asking hospitals to remove certain pumps because of the risk of an alarm that could interrupt treatment.
By Elise Reuter • Dec. 13, 2024 -
Permission granted by Augmedics
Augmedics names Paul Ziegler as CEO
Augmedics sells an augmented reality headset that allows spine surgeons to view virtual images of the patient’s bones and surgical instruments inside the body. Ziegler is the former CEO of Viewray.
By Nick Paul Taylor • Dec. 13, 2024 -
Permission granted by Endoquest Robotics
Endoquest robotic system gets FDA OK to launch clinical trial
A pivotal study of the robotic platform in colorectal surgery will begin at five hospitals in early 2025.
By Susan Kelly • Dec. 13, 2024 -
Permission granted by Capstan Medical
Capstan Medical raises $110M for heart valve with robotic system
The startup’s third round of financing includes support from Intuitive Surgical’s venture capital arm.
By Susan Kelly • Dec. 12, 2024 -
Leon Neal / Staff via Getty Images
4 takeaways from the FDA’s first digital health advisory committee
Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology, such as the use of complex models that can change quickly.
By Elise Reuter • Dec. 12, 2024 -
Mario Tama / Staff via Getty Images
Masimo lays off 75 employees in California
Under new leadership, the patient monitoring company is allocating resources to fewer projects as it focuses on market opportunities that address unmet needs, a spokesperson said.
By Susan Kelly • Dec. 11, 2024 -
skynesher via Getty Images
Patterson, a dental products distributor, agrees to $4.1B sale to healthcare investor
Last week, Patterson Companies announced it would seek strategic alternatives after the company’s profit decreased by one-third in its fiscal second quarter.
By Elise Reuter • Dec. 11, 2024 -
Chip Somodevilla via Getty Images
How Trump’s second term will affect the medtech industry
From M&A and tariffs to new health leaders, here are the top issues for the medtech industry to watch when President-elect Donald Trump returns to office.
By Ricky Zipp • Dec. 10, 2024 -
Permission granted by Vicarious Surgical
Vicarious Surgical CFO William Kelly stepping down in January
Kelly’s departure “does not instill confidence” but shouldn’t affect the robot developer’s timeline to market, said BTIG analyst Ryan Zimmerman.
By Susan Kelly • Dec. 10, 2024 -
Courtesy of Intuitive
Intuitive’s da Vinci beats non-robotic surgeries in cancer meta-analysis
Rates of postoperative complications, readmissions and death were lower after robotic surgeries than laparoscopic and open procedures.
By Nick Paul Taylor • Dec. 10, 2024 -
Just_Super via Getty Images
AI-enabled apps top ECRI’s list of health tech hazards in 2025
Other health tech hazards on ECRI’s annual list include the unmet technology support needs of home care patients, cybersecurity threats and substandard or fraudulent medical devices.
By Nick Paul Taylor • Dec. 9, 2024
