Medical device makers have been rushing to add AI to their products. While proponents say the new technology will revolutionize medicine, regulators are receiving a rising number of claims of patient ...

Since AI was added to the device, the FDA has received unconfirmed reports of at least 100 malfunctions and adverse events.

Subvisible particle testing addresses regulatory limits for particulate matter in parenteral drugs, ophthalmic solutions, and lipid emulsions.