FDA: Page 2

  • Dexcom's Stelo continuous glucose monitor.
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    Courtesy of Business Wire
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    Dexcom receives warning letter based on FDA inspections of 2 plants

    The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek clearance for new products.

    By • March 10, 2025
  • FDA administrator nominee Martin Makary speaks at a Senate confirmation hearing
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    Kayla Bartkowski via Getty Images
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    Following FDA cuts, Trump nominee Makary vows ‘independent’ staff review

    The Johns Hopkins surgeon highlighted rapid growth at the agency, but pledged key staff will have “all the resources they need to do their job well.”

    By Jonathan Gardner • March 6, 2025
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    Sitthiphong via 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
  • A person in a business suit speaks into a microphone.
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    Kayla Bartkowski via Getty Images
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    Makary, under review to run FDA, evades pressure to reinstate canceled vaccine meeting

    Questioned by senators at a Thursday hearing, President Donald Trump's FDA nominee said he would reevaluate which scientific topics require an advisory committee's input.

    By Ned Pagliarulo • March 6, 2025
  • The HHS in DC
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    Alex Wong / Staff via Getty Images
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    Trump administration policies could create headwinds across healthcare: Fitch

    The credit ratings agency is most concerned about Medicaid cuts and how government layoffs will affect device approvals.

    By Susanna Vogel • March 5, 2025
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips pulls endovascular implant from market after 20 injuries

    Philips stopped selling its Tack endovascular system because of cases where additional interventions were needed to remove the implant.

    By • March 5, 2025
  • A photo of Johnson & Johnson's pulsed field ablation system for atrial fibrillation.
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    Courtesy of Johnson & Johnson
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    FDA recall notice details J&J pause of Varipulse

    Four of the 132 patients treated with Varipulse in the first two months of the U.S. launch had a form of stroke shortly after surgery.

    By • March 3, 2025
  • A person sits at a desk, smiling, with a square device on top of a stack of notebooks. They are looking at a laptop.
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    Permission granted by Tandem Diabetes Care
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    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.
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    Grandbrothers via Getty Images
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    ‘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
  • exterior of the U.S. Department of Health and Human Services
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    Alex Wong via Getty Images
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    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
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    Sarah Silbiger via Getty Images
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    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"
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    Courtesy of Medtronic
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    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.
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    Sarah Silbiger via Getty Images
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    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.
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    Sarah Silbiger via Getty Images
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    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
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    Courtesy of Medtronic
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    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
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    Rebecca Noble via Getty Images
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    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."
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    Retrieved from Screenshot: The Food and Drug Administration.
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    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.
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    Andrew Harnik via Getty Images
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    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
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    Sarah Silbiger via Getty Images
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    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.
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    Courtesy of Medtronic
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    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.
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    Win McNamee via Getty Images
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    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.
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    Retrieved from Olympus on February 03, 2025
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    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.
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    Elise Reuter/MedTech Dive
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    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.
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    Courtesy of Intuitive Surgical
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    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.
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    Sarah Silbiger via Getty Images
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    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."
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    Retrieved from Screenshot: The Food and Drug Administration.
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    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