FDA classifies recall of Medtronic embolization devices as 'most serious'
The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic's embolization device as "most serious", ...
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 ...
GlobalData on MSN9d
Nearly a third of FDA medical device adverse event reports filed late
A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
Oops! Trump Accidentally Fired FDA Medical Device Reviewers
The Food and Drug Administration is scrambling to bring back hundreds of critical workers laid off en masse by DOGE.
Nearly a third of FDA medical device adverse events reported late: study
Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...
MedTech Dive3d
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 ...
FDA moves to rehire medical device, food safety and other staffers fired days earlier
The reversal is the latest example of President Donald Trump and billionaire Elon Musk’s chaotic approach to cost-cutting, which has resulted in several agencies firing, and then scrambling to rehire, ...
DexCom Stock Drops as Diabetes Devices Maker Gets FDA Warning Letter
DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.
Modern Healthcare3d
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.
Minn. Police Test Devices to Catch Drug-Impaired Drivers. How'd They Do?
Minnesota law enforcement officers tried out two devices that can detect six classes of drugs and chemicals that can impair ...
MedTech Dive7d
Dr. Oz stresses need for faster Medicare coverage of new devices during confirmation hearing
Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical ...
STAT9d
Study reveals how often medical device makers report safety incidents late to FDA
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...