MedPage Today on MSN

FDA Warns on Unauthorized Blood Pressure Measuring Devices

The risks of using unauthorized BP devices, the FDA said, include failure to detect changes in BP, delays in seeking ...
California Healthline

Lawmakers Ask FDA To Alter Device Safety Databases

On Wednesday, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) sent a letter asking FDA to overhaul two databases that provide public information about medical device safety. The letter ...
GlobalData on MSN

Nearly a third of FDA medical device adverse event reports filed late

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug ...

Nearly a third of FDA medical device adverse events reported late: study

Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...
MedPage Today on MSN

FDA Warns Against Dubious Infant Monitors Claiming to Prevent Sudden Infant Death

Indeed, challenges have persisted when it comes to SUID, as cases rose during the pandemic and reached 3,700 cases in the U.S ...
MedCity News

FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday. The recall comes years after surgeons say they ...
MedTech Dive

FDA warns on unauthorized blood pressure, infant monitoring devices

Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.