Medical Devices
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Courtesy of Outset Medical
Outset Medical appoints Renee Gaeta as CFO
Gaeta’s last role was a brief stint at Shockwave, which named her CFO two months before accepting J&J’s $13.1 billion takeover offer.
By Nick Paul Taylor • June 5, 2025 -
Neuralink raises $650M to help expand patient access
Elon Musk’s brain implant startup said five people with severe paralysis are now using the device.
By Elise Reuter • June 4, 2025 -
Sarah Silbiger via Getty Images
Smiths Medical recalls infusion pumps over 3 problems
Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm.
By Nick Paul Taylor • June 4, 2025 -
Courtesy of Johnson & Johnson
J&J may take a softer tariff hit after US-China pause, CFO says
Joseph Wolk told an investor conference that the company’s tariff estimate is a “moving target” as trade talks continue with China and Europe and Section 232 investigations are ongoing.
By Susan Kelly • June 4, 2025 -
Thomas Andreas via Getty Images
Clairity receives FDA OK for breast cancer risk prediction tool
The startup received de novo authorization for the AI tool, the first of its kind that analyzes mammogram images to predict breast cancer risk over five years.
By Elise Reuter • June 3, 2025 -
Permission granted by Nvidia
Q&ANvidia’s David Niewolny on the future of AI in medical devices
Nvidia, which is already working with J&J and Medtronic, plans to partner with medtech companies to build platforms for AI-enabled robotics, imaging and other features.
By Elise Reuter • June 2, 2025 -
Permission granted by Beta Bionics
Q&ABeta Bionics CEO, CFO on how to take a company public
CEO Sean Saint and CFO Stephen Feider spoke about what’s different now that the company is public and the long journey of pursuing an IPO.
By Ricky Zipp • June 2, 2025 -
Mario Guti via Getty Images
Bivacor wins FDA breakthrough nod for titanium total artificial heart
The company has so far treated patients who were weeks or months away from a transplant, but the device is theoretically suitable for longer-term use.
By Nick Paul Taylor • June 2, 2025 -
ventdusud via Getty Images
The medtech IPO window is finally open. Or is it?
After a three-year IPO drought, the industry is questioning whether the window for medtech public offerings is open following a small burst of activity.
By Ricky Zipp • Updated June 3, 2025 -
Courtesy of Boston Scientific
Boston Scientific plans changes to expected $200M tariff hit as situation shifts
The company also shared more details of its exit from the TAVR market and the impact of FDA layoffs on product review times.
By Nick Paul Taylor • May 29, 2025 -
Courtesy of Boston Scientific
Boston Scientific ends TAVR sales; J&J shares Monarch robot data
Boston Scientific said it would halt worldwide sales of its Acurate devices due to “increased clinical and regulatory requirements.”
By Elise Reuter • May 28, 2025 -
Sarah Silbiger via Getty Images
FDA finds Chinese lab copied or falsified data, endangering patients
The FDA said the findings raise doubts about the reliability and viability of premarket submissions based on the company’s data.
By Nick Paul Taylor • May 28, 2025 -
Permission granted by Abbott
Abbott wins FDA approval for mitral valve replacement device, teeing up Edwards competition
Abbott said the Tendyne system addresses a significant unmet need in cardiac care, providing an option for patients ineligible for open heart surgery and whose valves cannot be successfully repaired with MitraClip.
By Susan Kelly • May 28, 2025 -
Courtesy of Zimmer Biomet
Zimmer hires former Nevro CEO Kevin Thornal
Thornal will join the orthopedics company as group president for global businesses and the Americas, a newly created position.
By Susan Kelly • May 27, 2025 -
Tasos Katopodis via Getty Images
Trump calls for 50% tariffs on EU
The duties are slated to take effect July 9 as the bloc and the U.S. reengage on trade talks, the president said.
By Philip Neuffer • Updated May 27, 2025 -
Permission granted by Becton Dickinson
BD recalls esophagogastric tubes linked to 2 serious injuries, 1 death
A problem when preparing the devices for use can delay diagnosis or treatment, leading BD to update its instructions.
By Nick Paul Taylor • May 27, 2025 -
HadelProductions via Getty Images
Stryker wins FDA clearance for minimally invasive back pain treatment
The company will compete with a device Boston Scientific acquired for $850 million.
By Nick Paul Taylor • May 22, 2025 -
Courtesy of Medtronic
Why Medtronic plans to spin out its diabetes business
While some analysts questioned why Medtronic would leave a fast-growing market, others backed the company’s plan to focus on segments with higher margins.
By Elise Reuter • May 22, 2025 -
Mario Tama via Getty Images
Cost cuts, production shifts: How medtech firms are managing tariffs
Many companies forecast specific tariff charges. Then the White House and China agreed to a 90-day pause in their trade standoff.
By Susan Kelly • May 22, 2025 -
ArLawKa AungTun via Getty Images
Merit buys hemostatic device maker Biolife for $120M
Merit CEO Fred Lampropoulos said Biolife’s StatSeal and WoundSeal devices “address an estimated $350 million global market opportunity.”
By Nick Paul Taylor • May 21, 2025 -
Courtesy of GE Healthcare
AI in medtech is booming. Track new devices here.
The Food and Drug Administration has authorized more medical devices that incorporate artificial intelligence. Keep track of the latest developments in this database.
By Elise Reuter , Jasmine Ye Han • May 20, 2025 -
Courtesy of Johnson & Johnson
J&J subsidiary ordered to pay $147M for violating antitrust rules
A jury found that Biosense Webster withheld services to hospitals using reprocessed catheters.
By Elise Reuter • May 20, 2025 -
Courtesy of EndoQuest Robotics
EndoQuest, Virtuoso begin clinical trials for surgical robots
EndoQuest Robotics completed two procedures with its endoluminal system, while Virtuoso Surgical successfully performed bladder lesion excision in six patients.
By Susan Kelly • May 19, 2025 -
Win McNamee via Getty Images
US signals reciprocal tariffs will return for some countries
The White House will alert countries of their specific rates in the next two to three weeks, President Donald Trump said Friday.
By Philip Neuffer • Updated May 20, 2025 -
iStock / Svitlana Hulko
Sponsored by PaxxusBeyond sterility: The quiet engineering challenge behind every safe medical device
Inside the evolving science of sterilization compatibility and why your next packaging decision might improve patient outcomes.
May 19, 2025
