FDA

  • An image of two Smiths Medical white plastic implantable ProPort devices against a white background.
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    Retrieved from ICU Medical on March 21, 2025
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    Smiths Medical recalls port implants, warns on endotracheal tubes

    The business, acquired by ICU Medical in 2022, has been dealing with a series of recalls and quality issues over the past several years.

    By • March 21, 2025
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    Stock via Getty Images
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    FDA posts early alert after Calyxo urinary stone device tied to death

    The alert describes a problem that can lead to excessive pressure in the kidney during procedures to remove urinary stones.

    By • March 21, 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
  • 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 recalls embolization devices tied to 17 injuries, 4 deaths

    Medtronic will remove one model of Pipeline Vantage devices from where they’re used and sold and will update the instructions for another model.

    By • March 19, 2025
  • Monogram Technologies' robotic surgery system is displayed against a gray background.
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    Permission granted by Monogram Technologies
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    Monogram robot wins FDA OK; Vicarious hit by supplier woes

    Monogram Technologies secured 510(k) clearance for its robotic knee replacement system, while Vicarious Surgical blamed supply chain issues for delaying its regulatory timeline.

    By • March 19, 2025
  • A sign for the FDA is displayed outside the agency's headquarters in Silver Spring, Maryland.
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    Sarah Silbiger via Getty Images
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    Top device firms report safety data late: BMJ

    BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study found.

    By • March 18, 2025
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    Sarah Silbiger via Getty Images
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    FDA adds hemodialysis devices to shortage list amid B. Braun disruption

    The disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.

    By • March 17, 2025
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    Retrieved from Screenshot: Johnson & Johnson on March 13, 2025
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    J&J’s Monarch robot wins FDA nod for AI software update

    Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.

    By • March 13, 2025
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    Sarah Silbiger via Getty Images
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    FDA accuses Mid-Link of copying or falsifying medical device test data

    The agency will reject all data from the Chinese service provider’s studies after Mid-Link failed to address concerns outlined in a warning letter last year, FDA officials said.

    By • March 12, 2025
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    Stock via Getty Images
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    Douglas Kelly, deputy science director at FDA’s device center, leaves agency

    Kelly, who made several key hires at the CDRH and helped negotiate the last user fee agreement, announced his departure in a LinkedIn post Sunday.

    By • March 11, 2025
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    Jessica McGowan/Getty Images via Getty Images
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    The top 3 impacts of Trump’s health data purge

    Interrupted access to health-related data has already led to worse outcomes and could undermine faith in the U.S. healthcare system, experts say.

    By Michael Brady • March 10, 2025
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    FG Trade via Getty Images
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    New FDA pulse oximetry guidelines could stall under Trump

    The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts raised concerns that it might not be finalized.

    By • March 10, 2025
  • 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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    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
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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
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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
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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