Medical Devices


  • Outset Medical's Tablo Hemodialysis System.
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    Courtesy of Outset Medical
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    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 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 June 4, 2025
  • A sign for the FDA is displayed outside the agency's headquarters in Silver Spring, Maryland.
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    Sarah Silbiger via Getty Images
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    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 June 4, 2025
  • A wall bearing the Johnson & Johnson logo is seen outside of an office building.
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    Courtesy of Johnson & Johnson
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    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 June 4, 2025
  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
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    Thomas Andreas via Getty Images
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    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 June 3, 2025
  • Professional photo of David Niewolny
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    Permission granted by Nvidia
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    Q&A

    Nvidia’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 June 2, 2025
  • A group of people cheering inside the Nasdaq building, standing behind a podium.
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    Permission granted by Beta Bionics
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    Q&A

    Beta 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 June 2, 2025
  • The logo of the Food and Drug Administration is seen in a close-up view of the agency's website.
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    Mario Guti via Getty Images
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    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 June 2, 2025
  • Famous Wall street and the building in New York, New York Stock Exchange with patriot flag
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    ventdusud via Getty Images
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    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 Updated June 3, 2025
  • Photo of Michael F. Mahoney, CEO of Boston Scientific.
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    Courtesy of Boston Scientific
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    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 May 29, 2025
  • Boston Scientific's Acurate neo2 TAVR device is shown close up against a white background.
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    Courtesy of Boston Scientific
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    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 May 28, 2025
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    Sarah Silbiger via Getty Images
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    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 May 28, 2025
  • The white Abbott Tendyne mitral valve is shown against a bright pink background.
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    Permission granted by Abbott
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    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 May 28, 2025
  • A headshot shows Kevin Thornal against a blurred background of a stone wall with green foliage.
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    Courtesy of Zimmer Biomet
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    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 May 27, 2025
  • President Donald Trump speaks to reporters with Speaker of the House Mike Johnson.
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    Tasos Katopodis via Getty Images
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    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
  • Becton Dickinson logo
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    Permission granted by Becton Dickinson
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    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 May 27, 2025
  • Imaging scans of a human spine are illuminated from behind for review.
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    HadelProductions via Getty Images
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    Stryker wins FDA clearance for minimally invasive back pain treatment

    The company will compete with a device Boston Scientific acquired for $850 million.

    By May 22, 2025
  • A person looks at a smartwatch while walking past packaged produce.
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    Courtesy of Medtronic
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    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 May 22, 2025
  • Shipping containers are stacked on a container ship at the Port of Los Angeles, as a truck passes above in front of the snow-capped San Gabriel Mountains, on February 7, 2023 in Los Angeles.
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    Mario Tama via Getty Images
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    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 May 22, 2025
  • M&A due diligence lawyers legal
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    ArLawKa AungTun via Getty Images
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    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 May 21, 2025
  • A group of people wearing blue scrubs and masks stands in an operating room. One person points to an image of lungs on a screen.
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    Courtesy of GE Healthcare
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    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 , May 20, 2025
  • A wall bearing the Johnson & Johnson logo is seen outside of an office building.
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    Courtesy of Johnson & Johnson
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    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 May 20, 2025
  • The physician console of EndoQuest Robotics' endoluminal robotic surgery system.
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    Courtesy of EndoQuest Robotics
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    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 May 19, 2025
  • President Donald Trump speaks at the presidential palace of the United Arab Emirates, on May 16, 2025, in Abu Dhabi.
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    Win McNamee via Getty Images
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    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
  • Medical instruments being prepared for a procedure.
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    iStock / Svitlana Hulko

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    Sponsored by Paxxus

    Beyond 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