Med Device Online3h
Improving Medical Device Testing With Robotic Automation
Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in ...
Unpacking the FDA’s non-recall recalls
The FDA and manufacturers routinely allow doctors and hospitals to continue using medical devices that could cause serious ...
pulmonologyadvisor4d
FDA Alert: Pulmonology Drug Approvals and Recalls, Medical Device Updates
FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and ...
STAT8d
Most cardiovascular devices with serious safety recalls aren’t tested in patients
The analysis comes as regulators investigate how the FDA authorizes medical devices and handles safety recalls.
GM, Ford, Daimler Truck, Kia among 653,000 vehicles recalled: Check car recalls here
General Motors is recalling 13,241 of its 2024 GMC Canyon vehicles, the NHTSA report said. The automobile manufacturer said, ...
MedPage Today8d
Are Regulators the Root of the Problem of Serious Device Recalls?
Short follow-up is another problem that often appears in the backstory of recalled cardiovascular devices, such as the ...
dvm3601d
FDA announces Smiths Medical ventilator recall
The FDA's Center for Veterinary Medicine (CVM) announced Smiths Medical’s recall of the PneuPAC paraPAC Plus P300 and ...
TCTMD8d
Little Pre- and Postmarket Testing for Most Recalled CV Devices
The majority of FDA-recalled devices made it to market via the 510(k) pathway, which doesn’t require new clinical or safety ...
FierceBiotech1d
FDA elevates 3 recalls of Smiths Medical ventilators, tracheostomy tubes
The FDA is elevating three sets of respiratory hardware recalls from Smiths Medical, covering portable ventilators and ...
Analysis finds cardiac devices recalled for safety reasons infrequently subjected to premarket or postmarket testing
A cross-sectional study of cardiovascular devices subject to Class I recalls from 2013 through 2022, found that most recalled ...
The Washington Post7d
Unpacking the FDA’s non-recall recalls
Good morning. I’m David Hilzenrath, a D.C.-based reporter for KFF Health News with an interest in medical product regulation. Had an experience with a medical device that you’d like to share?
HealthDay on MSN7d
Before and After Market Testing Rare for Cardiovascular Devices With Class I Recalls
Cardiovascular devices with Class I recalls appear to be rarely subjected to premarket or postmarket testing, according to a ...