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

IN 2021, a unit of healthcare giant Johnson & Johnson announced “a leap forward”: It had added artificial intelligence (AI) to a medical device used to treat chronic sinusitis, an inflammation of the ...

AI-powered medical devices are linked to injuries, recalls, and lawsuits as regulators struggle to oversee a fast-growing wave of artificial intelligence in healthcare.

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

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 base of a patient’s skull. In two other cases, patients each allegedly ...