FDA: Page 2

  • A modern office building with large reflective glass windows is shown behind a wide driveway and landscaped entrance. In the foreground, a white and orange monument sign reads "Intuitive Surgical" with the number "1020" vertically on the side.
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    Alamy
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    Intuitive Surgical recalls stapler reloads over issue linked to patient death

    The recall follows reports of incomplete staple lines in procedures using the company’s da Vinci surgical robots.

    By • March 19, 2026
  • A closeup of JenaValve's Trilogy transcatheter valve to treat aortic regurgitation.
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    Permission granted by JenaValve
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    JenaValve snags FDA approval in aortic regurgitation

    The approval comes two months after Edwards Lifesciences scuttled plans to buy JenaValve for $945 million amid opposition from the Federal Trade Commission.

    By • March 18, 2026
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Permission granted by Boston Scientific
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    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
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    Tasos Katopodis via Getty Images
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    FDA to unify agency’s ‘fragmented’ safety surveillance system

    Combining the disparate databases used to detect potential issues with drugs, vaccines and other products into a single dashboard will enhance their utility and cut costs, the agency said.

    By Kristin Jensen • March 12, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    Advita Ortho receives warning letter related to shoulder system

    Advita Ortho was formed after orthopedic implant maker Exactech sold its assets in bankruptcy.

    By • March 12, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    Medtech industry calls for FDA staffing transparency in MDUFA talks

    Stakeholders also discussed changing international user fees and the FDA’s spending trigger for the program.

    By • March 5, 2026
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    Alamy
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    Abbott wins FDA approval for updated heart failure monitoring device

    The company redesigned the reader to fit in a carry-on suitcase and be easier to use day to day.

    By • March 2, 2026
  • A person sits on a couch with a white patch on their upper arm and a rectangular device with a screen on their hip.
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    Courtesy of Beta Bionics
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    FDA warns Beta Bionics on unreported complaints, insulin pump changes

    The Food and Drug Administration warning letter detailed unreported low blood sugar and a software change to correct for delayed glucose readings.

    By • Feb. 26, 2026
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    Alamy
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    FDA posts early alert for safety issue with Impella heart pump devices

    The cassettes have an increased risk of purge leaks that can lead to the loss of hemodynamic support.

    By • Feb. 26, 2026
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    Mario Guti via Getty Images
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    Medline addresses bed fire risk linked to death

    The FDA said hand pendants and cords may overheat, causing the devices to spark, burn, melt, smoke and catch fire.

    By • Feb. 18, 2026
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    Anna Moneymaker via Getty Images
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    HHS elevates officials into Kennedy’s inner circle in advance of midterms

    The HHS secretary has four new senior advisors to help him “move faster and go further” on his Make America Healthy Again agenda. The appointments preempt the GOP’s midterm messaging push.

    By Rebecca Pifer Parduhn • Feb. 13, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    Novocure wins FDA approval to treat pancreatic cancer with electric fields

    Winning approval to target the 15,000 U.S. patients with locally advanced pancreatic cancer is the first step in a broader expansion in the tumor type.

    By • Feb. 13, 2026
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    Sarah Silbiger via Getty Images
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    FDA breakthrough program starts FY2026 at steady pace

    Orthopedics was the most active area over the second half of 2025, with the FDA issuing 13 breakthrough designations to devices in the therapeutic area.

    By • Feb. 9, 2026
  • 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 recalls coil systems used in aneurysm treatment

    Healthcare providers are advised to stop using the devices after a failure to detach was linked with four serious injuries and one death.

    By • Feb. 6, 2026
  • Medtronic's MiniMed 780G
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    Courtesy of Medtronic
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    Medtronic wins expanded FDA label for 780G insulin pump

    The 510(k) decision clears the device for use with ultra-rapid-acting insulins from Eli Lilly and Novo Nordisk.

    By • Feb. 5, 2026
  • Illustration of a heart with a metal, coiled wire going into it.
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    Courtesy of Abiomed
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    J&J corrects Impella heart pumps over issue linked to 22 serious injuries

    The urgent correction notice is the latest in a series of actions related to the safety of Impella devices.

    By • Feb. 4, 2026
  • A person sits on a couch with a white patch on their upper arm and a rectangular device with a screen on their hip.
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    Courtesy of Beta Bionics
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    Beta Bionics receives FDA warning letter

    The letter, which the FDA has not yet published, does not affect Beta Bionics’ ability to market, manufacture or distribute products, the company said.

    By • Feb. 2, 2026
  • A Grail employee in a white coat works in a lab.
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    Courtesy of Grail
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    Grail files for FDA approval of multi-cancer early detection test

    Premarket approval could help the company secure coverage from commercial payers and Medicare.

    By • Feb. 2, 2026
  • Aerial view of a sprawling Boston Scientific manufacturing plant
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    Courtesy of Boston Scientific
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    Top medtech trends to watch in 2026

    From M&A to surgical robotics and user fee negotiations, the medical device industry has a busy year ahead. Check out MedTech Dive’s roundup of the top medtech trends to watch in 2026.

    By • Jan. 29, 2026
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    Alamy
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    CDRH on track for review timelines despite staff cuts

    The Center for Devices and Radiological Health said it is on track to meet review times specified by user fee agreements, despite “resource challenges.”

    By • Jan. 29, 2026
  • A picture of five Ōura smart rings against a gold background.
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    Courtesy of Ōura
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    FDA guidance eases wearables oversight. But experts have questions about what’s next.

    Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.

    By • Jan. 27, 2026
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    Alamy
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    Integra recalls wound and burn devices amid reports of serious injuries

    Packaging failures could lead to breaches in the sterile barrier and patient infections.

    By • Jan. 23, 2026
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    Elise Reuter/MedTech Dive, data from MedTech Dive
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    AdvaMed leaders on tariffs, MDUFA and wearables

    AdvaMed CEO Scott Whitaker and Mick Farrell, new board chair of the trade group, weighed in on important issues for the medtech industry one year into the Trump administration.

    By • Jan. 22, 2026
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    Courtesy of Boston Scientific
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    Boston Scientific recalls stent over issue linked to 3 deaths

    The company said the deaths were associated with off-label or investigational use of the device.

    By • Jan. 20, 2026
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    Elise Reuter/MedTech Dive
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    Deep Dive

    5 topics to watch as MDUFA negotiations restart

    The next Medical Device User Fee Amendments, which will set how much the FDA can raise from the industry in fees over a five-year period, are expected to go to Congress this year.

    By • Jan. 14, 2026
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    Courtesy of Whoop
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    FDA exempts more wearable, AI features from oversight

    In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.

    By • Jan. 8, 2026