FDA denies exemption request for radiology AI devices

The FDA has denied a petition seeking to exempt certain radiology AI devices from premarket review requirements. The request, submitted Oct. 22, 2025, sought partial exemption from 510(k) requirements for computer-aided detection and diagnosis devices and triage and notification software. The FDA published the petition Dec. 29 and received more than 45 comments before the […] The post FDA denies exemption request for radiology AI devices appeared first on Becker's Hospital Review | He...