FDA: Page 2

  • 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
  • Front sign of FDA building Explore the Trendline➔
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
  • 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.

    The FDA has rolled out an AI tool agency-wide, while a proposed HHS budget shows large cuts for the National Institutes of Health.

    By MedTech Dive Staff • Updated June 6, 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
  • Front sign of FDA building
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    HHS overhaul

    FDA cuts outlined in draft HHS budget

    The draft budget would slash FDA’s budget authority, if approved by Congress.

    By • April 18, 2025
  • A person in a blue suit gestures while seated at a conference table.
    Image attribution tooltip
    Andrew Harnik via Getty Images
    Image attribution tooltip
    HHS overhaul

    Budget draft outlines Trump’s plan to slash federal health programs

    An OMB document proposes to cut the HHS budget by roughly one-third as well as eliminate several divisions and programs.

    By Sydney Halleman • April 17, 2025
  • A person speaks at a podium in front of a large, out-of-focus painting.
    Image attribution tooltip
    Win McNamee via Getty Images
    Image attribution tooltip
    Trump tariffs

    US launches probe that could set stage for pharma tariffs

    The Commerce Department has begun a so-called Section 232 investigation into the national security effects of the U.S. importing pharmaceuticals and their starting materials.

    By Ned Pagliarulo • Updated April 14, 2025
  • A female hematologist analyzes medical samples at a hospital laboratory.
    Image attribution tooltip
    andresr via Getty Images
    Image attribution tooltip
    Deep Dive

    A judge blocked the FDA’s plan to regulate LDTs. What now?

    One attorney said the ruling “isn’t quite the stake in the heart.”

    By • April 16, 2025
  • A surgeon in blue scrubs and a facemask examines a da Vinic robotic surgery system in an operating room.
    Image attribution tooltip
    Retrieved from Intuitive Surgical on April 11, 2025
    Image attribution tooltip

    Intuitive wins FDA clearance for single-port robotic surgery stapler

    CFO Jamie Samath said in January that the stapler clearance would trigger the start of “broad commercial efforts” for the single-port system.

    By • April 11, 2025
  • A person smiles and holds a spoon. A white patch is on their right upper arm.
    Image attribution tooltip
    Courtesy of Dexcom
    Image attribution tooltip

    Dexcom nets FDA clearance for 15-day CGM

    The longer wear time should improve Dexcom’s margins and help it compete with Abbott, RBC Capital Markets analyst Shagun Singh said.

    By • April 10, 2025
  • A person in a suit sits on a dias.
    Image attribution tooltip
    Kevin Dietsch via Getty Images
    Image attribution tooltip

    RFK Jr. won’t appear before Senate panel this week

    HELP committee chair Bill Cassidy, R-La., had invited Kennedy to testify April 10 on the sweeping layoffs of federal health workers Kennedy ordered last month. A hearing could still take place later. 

    By Ned Pagliarulo • April 8, 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
    HHS overhaul

    HHS layoffs characterized by confusion, errors

    The sweeping workforce reduction that began Tuesday was made worse by mistakes and poor communication, including directions for some CMS employees to contact a director who died last year.

    By Rebecca Pifer • Updated April 2, 2025
  • Front sign of FDA building
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    HHS overhaul

    HHS layoffs could imperil medical device cybersecurity, Democrats say

    The FDA has 3,500 jobs on the chopping block, which could hinder cybersecurity oversight, Democrats said during a House subcommittee hearing.

    By Emily Olsen • April 2, 2025
  • People wait in line outside of a glass door. A person in uniform holds a gloved hand to the door.
    Image attribution tooltip
    Kevin Dietsch via Getty Images
    Image attribution tooltip
    HHS overhaul

    ‘Just goodbyes and crying’: CDRH hit in HHS mass layoffs

    Teams working on communications and policy were cut from the agency on April 1, according to multiple FDA workers interviewed by MedTech Dive.

    By • April 2, 2025