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 ...

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

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

For decades, Parkinson’s disease has been diagnosed only after tremors, stiffness and slowed movement are already disrupting daily life. Now a wave of research suggests a simple blood draw could ...

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