As AI enters the operating room, reports arise of botched surgeries and misidentified body parts

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 injuries.

Researchers from Johns Hopkins, Georgetown and Yale universities recently found that 60 FDA-authorized medical devices using AI were linked to 182 product recalls, according to a research letter published in the JAMA Health Forum in August. Their review showed that 43% of the recalls occurred less than a year after the devices were greenlighted. That’s about twice the recall rate of all devices authorized under similar FDA rules, the review noted.