Early Recalls and Clinical Validation Gaps in Artificial Intelligence-Enabled Medical Devices

Branden Lee, Patrick Kramer, Sara Sandri, Ritika Chanda, Crystal Favorito, Olivia Nasef, Joseph S Ross, Joshua Sharfstein, Tinglong Dai
JAMA Health Forum. 2025 Aug 1;6(8):e253172. doi: 10.1001/jamahealthforum.2025.3172.
Summary
This cross-sectional study examines whether lack of clinical validation and publicly traded manufacturer status were associated with recalls of artificial intelligence�enabled medical devices that had been cleared by the US Food and Drug Administration.