FDA

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    UK steps up push to align medtech regulations with the US

    Health regulators on both sides of the Atlantic are assessing alignment opportunities and exploring mutual recognition mechanisms.

    By • April 7, 2026
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    Sarah Silbiger via Getty Images
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    VDyne secures FDA nod to start pivotal trial for tricuspid valve

    With approval to study the transcatheter replacement device in patients with severe tricuspid regurgitation, VDyne is advancing a treatment to compete with Edwards Lifesciences’ Evoque system.

    By • April 6, 2026
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendline➔
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    Courtesy of Intuitive Surgical
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    Trendline

    Top 5 stories from MedTech Dive

    From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    Photo illustration: Mark Harris

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    Deep Dive

    ‘Cracks show’ as CDRH staff contend with heavy workloads

    Former device leaders said a culture of “fear and anxiety” has driven experienced staff from the Food and Drug Administration. An overburdened workforce has affected communications from the agency.

    By , • April 1, 2026
  • Two clinicians operate Distalmotion's Dexter robotic system in an operating room.
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    Permission granted by Distalmotion
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    Distalmotion targets ASC robotic gynecology programs with FDA filing

    The company is seeking clearance in additional gynecological indications to support outpatient use of its surgical robot.

    By • April 1, 2026
  • Medtronic's Stealth AXiS system.
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    Courtesy of Medtronic
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    Medtronic wins FDA clearance for robot in cranial, ENT surgeries

    The surgical navigation and robotics system is part of the company’s push to expand its share of the $15 billion cranial and spinal technologies market.

    By • March 30, 2026
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    Courtesy of Philips
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    Philips wins FDA clearance for imaging device developed with Edwards

    The system uses AI to optimize the placement of Edwards’ mitral valve repair device.

    By • March 27, 2026
  • GE HealthCare's Photonova Spectra photon-counting CT system is shown in a room.
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    Permission granted by GE HealthCare
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    GE HealthCare wins FDA nod for photon-counting CT technology

    The 510(k) decision clears the company to challenge Siemens Healthineers for an emerging part of the CT imaging sector.

    By • March 24, 2026
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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
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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
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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
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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
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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
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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
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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
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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