Health

Reveal linq: FDA malfunction report involving AI

The FDA received a malfunction report involving Reveal linq, made by Medtronic europe sarl. It was reported that the implantable cardiac monitor (icm) experienced false pause episodes due to undersensing. it was reported that representative stated the customer is concerned that the artificial intelligence (ai) algorithm adjudicated some pause episodes as false when they determined to be true. the icm remains in the patient. no patient complications have been reported as a result of this event.