Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs
Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...
Fierce Biotech3d
FDA's novel medical device clearances slow to a crawl
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...
STAT4d
New tests for Alzheimer’s and cancer get FDA’s ‘breakthrough’ status
PathChat, a new AI model for pathology made by Modella AI, received breakthrough status in January. The device can digest ...
MyChesCo on MSN17h
FDA Unveils Key Updates on Rare Disease Advances, Food Safety, and Medical Innovations
The U.S. Food and Drug Administration (FDA) has released a series of announcements covering a wide range of initiatives and ...
FDA approves first at-home, over-the-counter test for STIs. But there's a catch.
The FDA announced Friday that it had approved the first at-home test for sexually transmitted infections, opening the pathway ...
Devdiscourse3d
FDA Layoffs Disrupt Medical Device and Tobacco Product Reviews
Health regulators at the FDA are struggling to meet review deadlines for medical devices and tobacco products due to recent ...
GovInfoSecurity4d
Reading the Tea Leaves in FDA's AI-Enabled Device Guidelines
While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...
Devdiscourse4d
FDA Struggles to Meet Mandates Amidst Workforce Reductions
The U.S. FDA faces challenges in meeting product review deadlines due to layoffs mandated by the Trump administration.
MedTech Dive3d
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 ...
Modern Healthcare11d
FDA deems Medtronic’s Pipeline Vantage recall ‘most serious’
The recall, which affects two models of Pipeline Vantage embolization devices, is linked to 17 injuries and four deaths.
STAT4d
RFK Jr. brings FDA under tighter control with HHS workforce cuts
FDA drug, medical device, or food reviewers and inspectors will not be among those fired, according to an HHS fact sheet. Instead, the cuts will target employees working on policy, human resources ...