FDA: Page 2
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Andrew Harnik via Getty Images
HHS overhaulBudget 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 -
Win McNamee via Getty Images
Trump tariffsUS 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 -
andresr via Getty Images
Deep DiveA 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 Susan Kelly • April 16, 2025 -
Retrieved from Intuitive Surgical on April 11, 2025
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 Nick Paul Taylor • April 11, 2025 -
Courtesy of Dexcom
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 Elise Reuter • April 10, 2025 -
Kevin Dietsch via Getty Images
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 -
Kevin Dietsch via Getty Images
HHS overhaulHHS 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 -
Sarah Silbiger via Getty Images
HHS overhaulHHS 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 -
Kevin Dietsch via Getty Images
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 Elise Reuter • April 2, 2025 -
Win McNamee via Getty Images
HHS overhaulHHS 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 -
Karen Ducey/Getty Images via Getty Images
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 Susan Kelly • April 1, 2025 -
Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
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 -
Courtesy of Visby Medical
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 Nick Paul Taylor • March 31, 2025 -
Anna Moneymaker via Getty Images
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 -
Courtesy of Dexcom
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 Elise Reuter • March 27, 2025 -
Kevin Dietsch/Getty Images via Getty Images
HHS overhaulHHS 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 , Ricky Zipp • Updated March 27, 2025 -
Kayla Bartkowski via Getty Images
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 -
Courtesy of Dexcom
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 Elise Reuter • March 26, 2025 -
Courtesy of Beacon Biosignals
Deep Dive5 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 Elise Reuter • March 25, 2025 -
Courtesy of Abbott Laboratories
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 Nick Paul Taylor • March 25, 2025 -
Retrieved from ICU Medical on March 21, 2025
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 Susan Kelly • March 21, 2025 -
Stock via Getty Images
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 Nick Paul Taylor • March 21, 2025 -
Courtesy of Medtronic
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 Nick Paul Taylor • March 19, 2025 -
Permission granted by Monogram Technologies
News roundupMonogram 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 Susan Kelly • March 19, 2025 -
Sarah Silbiger via Getty Images
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 Elise Reuter • March 18, 2025
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