FDA

  • The logo of the Food and Drug Administration is seen in a close-up view of the agency's website.
    Image attribution tooltip
    Mario Guti via Getty Images
    Image attribution tooltip

    Bivacor wins FDA breakthrough nod for titanium total artificial heart

    The company has so far treated patients who were weeks or months away from a transplant, but the device is theoretically suitable for longer-term use.

    By • June 2, 2025
  • Boston Scientific's Acurate neo2 TAVR device is shown close up against a white background.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    Boston Scientific ends TAVR sales; J&J shares Monarch robot data

    Boston Scientific said it would halt worldwide sales of its Acurate devices due to “increased clinical and regulatory requirements.”

    By • May 28, 2025
  • FDA
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA finds Chinese lab copied or falsified data, endangering patients

    The FDA said the findings raise doubts about the reliability and viability of premarket submissions based on the company’s data.

    By • May 28, 2025
  • Becton Dickinson logo
    Image attribution tooltip
    Permission granted by Becton Dickinson
    Image attribution tooltip

    BD recalls esophagogastric tubes linked to 2 serious injuries, 1 death

    A problem when preparing the devices for use can delay diagnosis or treatment, leading BD to update its instructions.

    By • May 27, 2025
  • Imaging scans of a human spine are illuminated from behind for review.
    Image attribution tooltip
    HadelProductions via Getty Images
    Image attribution tooltip

    Stryker wins FDA clearance for minimally invasive back pain treatment

    The company will compete with a device Boston Scientific acquired for $850 million.

    By • May 22, 2025
  • FDA administrator nominee Martin Makary speaks at a Senate confirmation hearing
    Image attribution tooltip
    Kayla Bartkowski via Getty Images
    Image attribution tooltip

    FDA sets stricter approval standards for COVID vaccines

    The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.

    By Delilah Alvarado • May 20, 2025
  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
    Image attribution tooltip
    Sarah Silbiger/Getty Images via Getty Images
    Image attribution tooltip

    FDA clears first blood test to aid Alzheimer’s diagnosis

    The FDA cleared the test for the early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.

    By • May 19, 2025
  • A women looks at Teal Health's at-home self-collection cervical cancer screening kit while at a counter.
    Image attribution tooltip
    Retrieved from Teal Health on May 13, 2025
    Image attribution tooltip

    Teal wins FDA approval for at-home cervical cancer screening device

    The company plans to start shipping the device in June, starting in California and then expanding nationwide.

    By • May 13, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
    Image attribution tooltip
    hapabapa via Getty Images
    Image attribution tooltip

    FDA, aiming to speed scientific reviews, names chief AI officer

    Commissioner Martin Makary also said the agency would roll out a generative AI system across its centers that will help FDA scientists spend less time on repetitive tasks.

    By • May 9, 2025
  • The flag of the UK flies in cloudy skies, the Big Ben featured in the foreground.
    Image attribution tooltip
    Jack Taylor via Getty Images
    Image attribution tooltip

    AdvaMed calls for ‘zero for zero’ medtech tariffs between US and UK

    AdvaMed and its British counterpart called for urgent action to ensure the situation “does not devolve into a crisis.”

    By • May 7, 2025
  • jurisdiction federal courts
    Image attribution tooltip
    Mariakray via Getty Images
    Image attribution tooltip
    HHS overhaul

    State attorneys general sue over ‘unconstitutional’ HHS restructuring

    The lawsuit alleges the Trump administration overstepped its authority in reshaping the federal health department and asked the court to reinstate workers laid off last month.

    By Susanna Vogel • May 7, 2025
  • Robert F. Kennedy Jr. stands in front of a podium, speaking with a hand raised.
    Image attribution tooltip
    Andrew Harnik via Getty Images
    Image attribution tooltip
    HHS overhaul

    RFK’s FDA layoffs could slow safety communications, experts warn

    The mass cuts, which included communications staff, could slow public notices on medical device recalls and other safety alerts.

    By • May 6, 2025
  • A closeup of Edwards Lifesciences' Sapien 3 heart valve.
    Image attribution tooltip
    Courtesy of Edwards Lifesciences
    Image attribution tooltip

    Edwards gains expanded TAVR label for asymptomatic patients

    The medical technology company expects the new indication to increase sales in its transcatheter aortic valve replacement business with more patients becoming eligible for the treatment.

    By • May 5, 2025
  • U.S. President Donald Trump watches as Health and Human Services Secretary Robert F. Kennedy Jr. (C) swears in Dr. Mehmet Oz (R) as the Medicare and Medicaid Services Administrator during a ceremony in the Oval Office at the White House on April 18, 2025 in Washington, DC.
    Image attribution tooltip
    Andrew Harnik / Staff via Getty Images
    Image attribution tooltip
    Tracker

    Trump policies are upending healthcare. Track the effect on the medtech industry here.

    AdvaMed’s CEO praised comments from FDA chief Martin Makary about Medicare covering breakthrough devices more quickly. Elsewhere, a court halted most of Trump’s tariff plans, but an appeals court blocked the ruling.

    By MedTech Dive Staff • Updated May 30, 2025
  • A building in front of a pond with the sign "Medtronic" on a stone wall.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic wins FDA approval for defibrillation lead

    Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, according to Medtronic.

    By • Updated May 5, 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

    ICU Medical receives FDA warning letter over infusion pumps

    Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

    By • April 29, 2025
  • Four medtronic Hugo surgical robots
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic submits Hugo soft tissue robot for FDA approval

    William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful U.S. competition.

    By • April 28, 2025
  • A person stands outside wearing a small, square device with a cord on their belt.
    Image attribution tooltip
    Permission granted by Medtronic
    Image attribution tooltip

    Medtronic seeks FDA nod for insulin pump, furthering Abbott collab

    Receiving FDA clearance would allow Medtronic to pair its pumps with a glucose monitor being developed for the company by Abbott.

    By • April 24, 2025
  • Trump signs an executive order at the Oval Office.
    Image attribution tooltip
    Anna Moneymaker via Getty Images
    Image attribution tooltip

    Device developers advance AI plans despite Trump uncertainty

    Trump administration policies have raised questions about how the FDA will regulate AI in medical devices. AdvaMed board members think the agency should keep its leading role.

    By • April 24, 2025
  • Front sign of FDA building
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA issues early alert for BD catheters due to leaks

    BD recalled certain intravascular catheters tied to reports of 10 serious injuries after finding an increase in cracks from “material fatigue.”

    By • April 21, 2025
  • Two gloved hands hold a flexible yellow strip with small dots on one end.
    Image attribution tooltip
    Courtesy of Precision Neuroscience
    Image attribution tooltip

    Precision Neuroscience receives FDA clearance for brain implant

    The electrode array, which can be implanted for 30 days to map brain activity, is a component of Precision Neuroscience’s planned brain-computer interface system.

    By • April 21, 2025
  • A person holds a phone, wearing a white patch on their forearm and an insulin pump on their hip.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic gets FDA approval to use Simplera Sync glucose sensor with insulin pumps

    The updated device allows users to pair the sensor with Medtronic’s insulin pumps, and is expected to grow the company’s diabetes business.

    By • April 21, 2025
  • A line of people stand outside the Switzer Memorial Building in Washington, D.C.
    Image attribution tooltip
    Kevin Dietsch via Getty Images
    Image attribution tooltip
    Deep Dive // HHS overhaul

    HHS layoffs may be illegal, legal experts say

    The federal health department sidestepped normal procedures as it laid off 10,000 employees, according to sources. One union has already filed an internal complaint, while at least two law firms are exploring suits.

    By Rebecca Pifer • April 21, 2025
  • An older patient in a hospital bed wearing a seizure-detecting headset with doctors around him.
    Image attribution tooltip
    Retrieved from Ceribell on April 17, 2025
    Image attribution tooltip

    Ceribell wins FDA nod for algorithm to detect pediatric seizures

    The clearance adds another feature for Ceribell to leverage as it tries to persuade hospitals to switch from conventional EEG systems.

    By • April 21, 2025
  • man in a navy suit with a red tie sits hands crossed at a desk with a microphone
    Image attribution tooltip
    Kayla Bartkowski via Getty Images
    Image attribution tooltip

    Makary seeks to limit industry’s role in FDA advisory panels

    Commissioner Martin Makary said the agency would, whenever possible, restrict drug company employees from participating as industry representatives on advisory committees.

    By Ned Pagliarulo • Updated April 18, 2025