FDA

  • 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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    FDA warns of neurosurgical supply disruptions

    Interruptions in the supply of neurosurgical patties, sponges and strips are expected to continue through 2026.

    By • May 6, 2026
  • Modern glass and metal office building with a reflective blue-tinted facade, set against a clear blue sky. In the foreground, a large black and white sign reads “Abbott” with the company’s stylized logo and the number “645.” The area has neatly cut grass and a few small trees.
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    Alamy
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    Abbott gets FDA nod, CE mark for AI-enabled imaging device

    The device joins a portfolio of vascular technologies that generated 9.5% sales growth on a comparable basis in the first quarter.

    By • May 4, 2026
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    Getty Images
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    Trendline

    Medical 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
  • Two black, rounded devices next to each other give the same reading of 102 mg/dL.
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    Courtesy of Trividia Health
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    FDA advises users of Trividia glucometer to switch to alternatives

    The potential for error code confusion to cause delayed or improper treatment led the FDA to recommend users transition to other blood glucose meters.

    By • April 30, 2026
  • Boston Scientific's Farawave pulsed field ablation catheter is shown against a white background.
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    Courtesy of Boston Scientific
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    4 studies to know from HRS 2026

    Boston Scientific, Abbott and Medtronic shared new cardiac device data at the annual Heart Rhythm Society meeting, where market share shifts in pulsed field ablation were on analysts’ minds.

    By • April 27, 2026
  • A concrete sign outside of a building reads "Department of Health & Human Services" wrapped around the HHS logo.
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    Kayla Bartkowski via Getty Images
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    CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices

    The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class III breakthrough medical devices.

    By • April 23, 2026
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    Permission granted by AAMI
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    CDRH Director Tarver previews AI guidance at AAMI event

    Michelle Tarver said the device center plans to finalize guidance on AI lifecycle management and provide some initial thoughts on generative AI following an advisory committee meeting last year.

    By • April 22, 2026
  • U.S. Health and Human Services Secretary Robert F. Kennedy Jr. testifies during a hearing of the House Education And Workforce Committee on Capitol Hill on April 17, 2026 in Washington, DC.
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    Heather Diehl/Getty Images via Getty Images
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    RFK Jr. defends HHS tenure, 12% proposed budget cut

    Republicans largely praised the HHS secretary’s track record during a marathon of House hearings last week, but some GOP lawmakers raised concerns about proposed budget cuts to the National Institutes of Health.

    By Emily Olsen • April 20, 2026
  • A CT imaging machine in a white room.
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    Courtesy of Philips
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    Philips secures FDA clearance for AI-enabled CT system

    The company aims to increase its share of the premium CT device market through 2028.

    By • April 17, 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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    FDA, medtech industry near MDUFA VI agreement

    The FDA said it intends to hire “substantial numbers” of medical device review staff as part of the agreement for the next medical device user fee amendments.

    By • April 9, 2026
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    John Moore via Getty Images
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    CDRH targets hospital readmissions with home device innovation challenge

    The center plans to pick nine devices to help support patients and caregivers after a hospital stay.

    By • April 9, 2026
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    Getty Images
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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
  • A stylized collage centers on a handheld medical device resembling a glucose monitor, overlaid on bold red and blue geometric shapes, with faint overhead images of empty office desks in the background and the word “REJECTED” repeated in gray text.
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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
  • A physician in blue scrubs and a mask looks at Philips' DeviceGuide images on a large screen.
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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
  • 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
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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
  • Modern glass and metal office building with a reflective blue-tinted facade, set against a clear blue sky. In the foreground, a large black and white sign reads “Abbott” with the company’s stylized logo and the number “645.” The area has neatly cut grass and a few small trees.
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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
  • A modern architectural design building featuring a red-brick façade with large glass windows displays a prominent sign of the Food and Drug Administration.
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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