FDA: Page 3

  • A surgeon in blue scrubs and a facemask examines a da Vinic robotic surgery system in an operating room.
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    Retrieved from Intuitive Surgical on April 11, 2025
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    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
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    Courtesy of Dexcom
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    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
  • the FDA Headquarters Explore the Trendline➔
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    Sara Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • A person in a suit sits on a dias.
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    Kevin Dietsch via Getty Images
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    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.
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    Kevin Dietsch via Getty Images
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    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
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    Sarah Silbiger via Getty Images
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    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.
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    Kevin Dietsch via Getty Images
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    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
  • Robert F. Kennedy Jr. stands in front of croded congressional room
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    Win McNamee via Getty Images
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    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.
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    Karen Ducey/Getty Images via Getty Images
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    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.
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    Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
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    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
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    Courtesy of Visby Medical
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    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.
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    Anna Moneymaker via Getty Images
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    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
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    Courtesy of Dexcom
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    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.
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    Kevin Dietsch/Getty Images via Getty Images
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    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
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    Kayla Bartkowski via Getty Images
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    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
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    Courtesy of Dexcom
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    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
  • A headband sits on a nightstand in front of a lamp
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    Courtesy of Beacon Biosignals
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    Deep Dive

    5 tips for building a predetermined change control plan

    The new framework is intended to make postmarket changes easier for products. Experts recommend having a clear roadmap and contacting regulators early.

    By • March 25, 2025
  • Abbott company sign outside
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    Courtesy of Abbott Laboratories

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    Abbott gets FDA nod to begin IVL trial after rivals buy up competition

    J&J acquired the IVL device maker Shockwave Medical last year for $13.1 billion, and Boston Scientific agreed to buy Bolt Medical in January for up to $664 million.

    By • March 25, 2025
  • 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
  • FDA headquarters sign
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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
  • 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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    News roundup

    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
  • Food And Drug Administration Headquarters In Maryland
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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
  • A flexible tube with a needle point is positioned in front of a hand holding a controller.
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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
  • 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 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