In 2021, a unit of healthcare giant Johnson & Johnson announced “a leap forward”: It had added artificial intelligence to a ...

AI-powered medical devices are linked to injuries, recalls, and lawsuits as regulators struggle to oversee a fast-growing ...

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.