The FDA has recalled Mercury Medical’s Neo-Tee T-Piece Resuscitator, a gas powered resuscitator intended primarily for ...
A recent study identified 157 cardiovascular devices recalled from 2013 to 2022. Recalls were commonly attributed to device ...
Here are three recent recalls reported to the FDA: ...
For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.