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

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

At least 1,357 medical devices using AI are now authorized by the FDA – double the number it had allowed through 2022 ...

Medical device makers have been rushing to add AI to their products. While proponents say the new technology will ...

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

Cerebrospinal fluid reportedly leaked from one patient’s nose. In another reported case, a surgeon mistakenly punctured the ...