FDA: Page 2
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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 -
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Sitthiphong via Getty Images
TrendlineMedical 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 -
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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 -
Sarah Silbiger via Getty Images
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 Nick Paul Taylor • March 17, 2025 -
Retrieved from Screenshot: Johnson & Johnson on March 13, 2025
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 Susan Kelly • March 13, 2025 -
Sarah Silbiger via Getty Images
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 Nick Paul Taylor • March 12, 2025 -
Stock via Getty Images
Douglas Kelly, deputy science director at FDA’s device center, leaves agency
Kelly, who made several key hires at the CDRH and helped negotiate the last user fee agreement, announced his departure in a LinkedIn post Sunday.
By Elise Reuter • March 11, 2025 -
Jessica McGowan/Getty Images via Getty Images
The top 3 impacts of Trump’s health data purge
Interrupted access to health-related data has already led to worse outcomes and could undermine faith in the U.S. healthcare system, experts say.
By Michael Brady • March 10, 2025 -
FG Trade via Getty Images
New FDA pulse oximetry guidelines could stall under Trump
The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts raised concerns that it might not be finalized.
By Elise Reuter • March 10, 2025 -
Courtesy of Business Wire
Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek clearance for new products.
By Nick Paul Taylor • March 10, 2025 -
Kayla Bartkowski via Getty Images
Following FDA cuts, Trump nominee Makary vows ‘independent’ staff review
The Johns Hopkins surgeon highlighted rapid growth at the agency, but pledged key staff will have “all the resources they need to do their job well.”
By Jonathan Gardner • March 6, 2025 -
Kayla Bartkowski via Getty Images
Makary, under review to run FDA, evades pressure to reinstate canceled vaccine meeting
Questioned by senators at a Thursday hearing, President Donald Trump's FDA nominee said he would reevaluate which scientific topics require an advisory committee's input.
By Ned Pagliarulo • March 6, 2025 -
Alex Wong / Staff via Getty Images
Trump administration policies could create headwinds across healthcare: Fitch
The credit ratings agency is most concerned about Medicaid cuts and how government layoffs will affect device approvals.
By Susanna Vogel • March 5, 2025 -
Patrik Stollarz / Staff via Getty Images
Philips pulls endovascular implant from market after 20 injuries
Philips stopped selling its Tack endovascular system because of cases where additional interventions were needed to remove the implant.
By Elise Reuter • March 5, 2025 -
Courtesy of Johnson & Johnson
FDA recall notice details J&J pause of Varipulse
Four of the 132 patients treated with Varipulse in the first two months of the U.S. launch had a form of stroke shortly after surgery.
By Nick Paul Taylor • March 3, 2025 -
Permission granted by Tandem Diabetes Care
Tandem’s insulin pump tech wins FDA nod for Type 2 diabetes
Tandem is following competitor Insulet’s lead with the second automated insulin delivery system indicated for Type 2 diabetes.
By Elise Reuter • Feb. 27, 2025
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