Nearly Half of FDA-Approved AI Devices Not Based On Real Patient Data
Researchers from the University of North Carolina have called for more rigorous testing of artificial intelligence (AI)-powered medical devices, following a comprehensive study of nearly three decades of U.S. Food and Drug Administration (FDA) authorizations.
Some devices used simulated images, not real patient data, which technically didn’t qualify as testing in real patients, also known as clinical validation.
https://www.zerohedge.com/medical/nearly-half-fda-approved-ai-devices-not-based-real-patient-data