At least 1,357 medical devices using AI are now authorized by the FDA – double the number it had allowed through 2022. Acclarent's owner, Integra LifeSciences, told Reuters there’s no evidence of a link between the AI technology and any alleged injuries. But the company also says on its site and in product literature that its AI technology, AccuRhythm AI, can misclassify actual abnormal heart rhythms or pauses. Medtronic said some of the incidents were related to problems with data display, not the AI technology. In their work, scientists tried to “break” the devices’ AI models, a former employee said.

Source: The Telegraph February 09, 2026 12:41 UTC