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 ...
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 ...
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 ...
Med Device Online1h
Improving Medical Device Testing With Robotic Automation
Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in ...
medtechdive19h
FDA names new head of medical device evaluation and quality
Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.
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 ...
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 ...
Medpage Today on MSN9d
Are Regulators the Root of the Problem of Serious Device Recalls?
Approved in 2019 based on the surrogate measure of vessel patency at 12 months, the Vici was later recalled in 2021 due to ...
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, ...
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 ...
Anker recalls three power banks due to fire risk - stop using them now
Design defects in three popular models spur Anker's second recall this year. Here's what you should do right away.
EPA Fines Austin-Based Cobb Tuning Over Emission Defeat Devices
The U.S. Environmental Protection Agency and U.S. Justice Department recently reached an agreement with COBB Tuning Products ...