FDA

  • 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
  • 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
  • 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 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

    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

    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.” The FDA is unlikely to challenge the court’s decision, but Congress could still take on the issue.

    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 Tuesday, according to multiple FDA workers interviewed by MedTech Dive.

    By • April 2, 2025
  • Robert F. Kennedy Jr. stands in front of croded congressional room
    Image attribution tooltip
    Win McNamee via Getty Images
    Image attribution tooltip
    HHS overhaul

    HHS begins layoffs in chaotic fashion

    The Trump administration sent out the first round of reduction-in-force notices early Tuesday morning, telling employees the cuts are necessary to improve efficiency.

    By Rebecca Pifer • April 1, 2025
  • A picture of a researcher standing in front of a testing machine in a laboratory.
    Image attribution tooltip
    Karen Ducey/Getty Images via Getty Images
    Image attribution tooltip

    Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

    The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

    By • April 1, 2025
  • A photo of FDA CBER Director Peter Marks delivering remarks at a public workshop on March 3, 2020.
    Image attribution tooltip
    Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
    Image attribution tooltip

    Peter Marks, FDA’s top vaccine official, resigns

    In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed “misinformation and lies.”

    By Ned Pagliarulo • March 31, 2025
  • A flat hand holds up an at-home STI test against a white bakcground
    Image attribution tooltip
    Courtesy of Visby Medical
    Image attribution tooltip

    FDA OKs first at-home test for 3 STIs

    Visby Medical’s at-home diagnostic, which can be purchased without a prescription, tests for chlamydia, gonorrhea and trichomoniasis.

    By • March 31, 2025
  • RFK Jr. strides down a Capitol Hill hallway thronged by aides and reporters.
    Image attribution tooltip
    Anna Moneymaker via Getty Images
    Image attribution tooltip
    HHS overhaul

    ‘Everything is word of mouth’: HHS employees face uncertainty in looming Trump layoffs

    Many HHS department heads and employees were unaware of plans to fire some 10,000 employees until they were announced Thursday, sources said.

    By Sydney Halleman , Ned Pagliarulo , Rebecca Pifer • March 28, 2025
  • The Dexcom G7 Continuous Glucose Monitoring (CGM) System
    Image attribution tooltip
    Courtesy of Dexcom
    Image attribution tooltip

    Dexcom rejects claims of unauthorized device changes in FDA warning letter

    A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its glucose sensors.

    By • March 27, 2025
  • Robert F. Kennedy Jr., U.S. President Donald Trump’s nominee for Secretary of Health and Human Services departs after testifying in a confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions at the Dirksen Senate Office Building on January 30, 2025 in Washington, D.C.
    Image attribution tooltip
    Kevin Dietsch/Getty Images via Getty Images
    Image attribution tooltip
    HHS overhaul

    HHS to cut 10,000 employees in major restructuring under RFK Jr.

    Advamed CEO Scott Whitaker said Thursday that “any reduction in force should be accompanied by policy and regulatory improvements that encourage innovation in medtech.”

    By Ned Pagliarulo , Rebecca Pifer , • Updated March 27, 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 confirmed by Senate as FDA commissioner

    The Johns Hopkins surgeon will helm the agency as layoffs loom and important decisions on treatments for rare and infectious diseases await.

    By Jonathan Gardner • March 26, 2025
  • The Dexcom G7 Continuous Glucose Monitor
    Image attribution tooltip
    Courtesy of Dexcom
    Image attribution tooltip

    Dexcom’s FDA warning letter reveals unauthorized changes to sensors

    Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, according to the warning letter.

    By • March 26, 2025