FDA

  • A person sits at a desk, smiling, with a square device on top of a stack of notebooks. They are looking at a laptop.
    Image attribution tooltip
    Permission granted by Tandem Diabetes Care
    Image attribution tooltip

    Tandem’s insulin pump tech wins FDA nod for Type 2 diabetes

    Tandem is following competitor Insulet’s lead with the second automated insulin delivery system indicated for Type 2 diabetes.

    By • Feb. 27, 2025
  • An entrance to a National Institutes of Health building is lit by the sun on a clear day.
    Image attribution tooltip
    Grandbrothers via Getty Images
    Image attribution tooltip

    ‘Fear and uncertainty’: Biotech investors warn of impact from NIH research cuts

    The Trump administration’s plans to reduce NIH grant funding could have long-term consequences for the U.S. drug industry, investors said.

    By Gwendolyn Wu • Feb. 27, 2025
  • Close up of hand touching smartwatch with health app on the screen. Explore the Trendline➔
    Image attribution tooltip
    Sitthiphong via Getty Images
    Image attribution tooltip
    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
  • exterior of the U.S. Department of Health and Human Services
    Image attribution tooltip
    Alex Wong via Getty Images
    Image attribution tooltip

    CAP urges HHS to revoke lab developed test rule, citing Trump order

    The pathologists group wants the regulation terminated in light of an executive order from President Trump that calls for federal agencies to “alleviate unnecessary regulatory burdens.”

    By • Feb. 26, 2025
  • Food And Drug Administration Headquarters In Maryland
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA brings back some fired device staff

    An industry source said “most, if not all” of the people at the CDRH who were recently dismissed are now being asked to return.

    By • Feb. 24, 2025
  • A rounded, metallic device says "Medtronic Percept PC"
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic gains FDA OK for self-adjusting DBS system for Parkinson’s

    The brain-computer interface technology personalizes therapy based on an individual’s brain activity.

    By • Feb. 24, 2025
  • A sign reading Food and Drug Administration is seen above a door to a government building.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    In FDA job cuts, experts see threat of far-reaching impact

    "Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf.

    By Jonathan Gardner , Delilah Alvarado • Feb. 21, 2025
  • A sign reading Food and Drug Administration is seen above a door to a government building.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    Device industry scrambles as FDA job cuts cause delays

    The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an attorney said.

    By • Feb. 20, 2025
  • Medtronic's Hugo surgical robot system
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic nears FDA submission for Hugo robot

    CEO Geoff Martha said Medtronic would submit its application for urological procedures to the Food and Drug Administration by the end of March.

    By • Feb. 18, 2025
  • RFK Jr. shakes hands with Donald trump on stage with a crowd behind watching
    Image attribution tooltip
    Rebecca Noble via Getty Images
    Image attribution tooltip

    RFK Jr. confirmed as HHS secretary

    Robert F. Kennedy Jr., a prominent vaccine critic, was confirmed Thursday by the U.S. Senate in a 52-48 vote to serve as the nation’s top health official.

    By Emily Olsen • Feb. 13, 2025
  • An FDA webpage reads "Page Not Found."
    Image attribution tooltip
    Retrieved from Screenshot: The Food and Drug Administration.
    Image attribution tooltip

    Judge orders FDA, health agencies to restore removed webpages

    District Judge John Bates wrote the removals harm “everyday Americans, and most acutely, underprivileged Americans, seeking healthcare.”

    By • Feb. 12, 2025
  • A person in a black suit jacket gestures as another listens while seated behind a desk.
    Image attribution tooltip
    Andrew Harnik via Getty Images
    Image attribution tooltip

    Trump orders agencies to plan for ‘large-scale’ job cuts

    While Trump’s executive order provides substantial power to Elon Musk’s DOGE effort, it’s not specifically targeted to health agencies like the FDA.

    By Ned Pagliarulo • Feb. 12, 2025
  • FDA headquarters with sign in foreground
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA posts early alert about BD device linked to 30 injuries, 4 deaths

    The alert was posted one day after BD sent customers a letter warning about the risk of atherectomy catheters breaking.

    By • Feb. 10, 2025
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic recall of brain fluid drainage systems linked to 15 injuries

    The company will keep the systems on the market but is asking providers to check devices for visible cracks and return affected devices.

    By • Feb. 4, 2025
  • Robert F. Kennedy Jr. sits behind a desk in a Senate hearing room.
    Image attribution tooltip
    Win McNamee via Getty Images
    Image attribution tooltip

    RFK Jr. clears key hurdle on path to HHS secretary

    A key Senate committee voted to advance Robert F. Kennedy’s nomination even after some legislators raised concerns about his previous vaccine stances and confusion surrounding programs like Medicare and Medicaid.

    By Sydney Halleman , Delilah Alvarado , Jonathan Gardner • Feb. 4, 2025
  • The Olympus U.S. headquarters building is shown against a clear blue sky.
    Image attribution tooltip
    Retrieved from Olympus on February 03, 2025
    Image attribution tooltip

    FDA labels recall of discontinued Olympus endoscope part as Class I

    The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of the device.

    By • Feb. 3, 2025
  • A person sits on a white couch and speaks.
    Image attribution tooltip
    Elise Reuter/MedTech Dive
    Image attribution tooltip

    Troy Tazbaz, CDRH digital health leader, resigns

    Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.

    By • Jan. 31, 2025
  • A picture of the surgeon's console for Intuitive Surgical's da Vinci 5 surgical robot.
    Image attribution tooltip
    Courtesy of Intuitive Surgical
    Image attribution tooltip
    2025 outlook

    Top medtech trends in 2025: New products and M&A are bright spots, but Trump brings uncertainty

    Experts highlighted surgical robotics, artificial intelligence and M&A as top trends this year. However, the Trump administration could create challenges for the industry.

    By • Jan. 31, 2025
  • A sign reading Food and Drug Administration is seen above a door to a government building.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA warns about patient monitor cybersecurity vulnerabilities

    Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the devices, the FDA warned.

    By • Jan. 31, 2025
  • An FDA webpage reads "Page Not Found."
    Image attribution tooltip
    Retrieved from Screenshot: The Food and Drug Administration.
    Image attribution tooltip

    FDA webpages on clinical trial diversity removed after Trump orders

    The website changes raise concerns about “the interference of politics with the study and the practice” of science and medicine, a physician said.

    By • Jan. 27, 2025
  • Front sign of FDA building
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    Sara Brenner named acting FDA commissioner

    Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new leader is confirmed.

    By • Jan. 24, 2025
  • A person in a business suit speaks at a lectern with a U.S. flag in the background.
    Image attribution tooltip
    Rebecca Noble via Getty Images
    Image attribution tooltip

    Senate sets date to vet RFK Jr.’s nomination to lead HHS

    The Senate Finance Committee will meet on Jan. 29 to discuss the confirmation of RFK Jr., whose stances on vaccines and abortion have raised questions from Democrats and Republicans alike.  

    By Kristin Jensen • Jan. 23, 2025
  • Two people face each other and speak in a dark room in front of screens showing a black and white image of a lung.
    Image attribution tooltip
    Retrieved from Mass General Brigham on January 22, 2025
    Image attribution tooltip
    Deep Dive // 2025 outlook

    AI in medtech is taking off. Here are 4 trends to watch in 2025.

    New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.

    By • Jan. 22, 2025
  • A person speaks at a podium on a stage.
    Image attribution tooltip
    Elise Reuter/MedTech Dive
    Image attribution tooltip

    Tarver warns that US device supply chain vulnerabilities could harm patients

    The new director of the FDA’s device center contrasted a European rule with the lack of mandatory reporting requirements for potential device shortages in the U.S.

    By • Jan. 17, 2025
  • Close up of a hand holding a spiral, plastic device with metal spurs.
    Image attribution tooltip
    Retrieved from Hologic on January 16, 2025
    Image attribution tooltip

    Hologic receives FDA warning letter over Biozorb implantable markers

    Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.

    By • Updated Jan. 16, 2025
  • Image attribution tooltip
    Patrik Stollarz / Staff via Getty Images
    Image attribution tooltip

    Philips recall of heart monitor software tied to 109 injuries, 2 deaths

    Some electrocardiogram events, such as atrial fibrillation or abnormally rapid heartbeats, over two years were not reviewed by healthcare professionals due to a data routing issue.

    By • Jan. 14, 2025