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 M. Sharfstein, Tinglong Dai
Abstract
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.
Topics & Concepts
ClearanceFood and drug administrationBusinessComputer scienceData scienceMedicineMedical emergencyUrologyArtificial Intelligence in Healthcare and EducationQuality and Safety in HealthcareBiomedical and Engineering Education