Only three of 1,357 FDA-cleared AI devices tested patient outcomes

https://www.news-medical.net/news/20260820/Only-three-of-1357-FDA-cleared-AI-devices-tested-patient-outcomes.aspx Hundreds of AI tools are entering clinical care, but researchers traced how quickly the evidence thins out when the focus shifts from regulatory authorization to trials that measure what actually happens to patients. A recent study published in the journal PLOS Digital Health found a significant gap between the number of artificial intelligence (AI)-based medical devices cleared or approved by the United States Food and Drug Administration (US FDA) and the number evaluated for patient outcomes.