FDA-cleared medical AI rarely tested for real-world benefits

A new analysis finds that of 1,357 artificial intelligence-based medical devices authorized by the U.S. Food and Drug Administration for use in patient care, only three have been evaluated for their impact on patient-centered outcomes such as mortality, stroke, hospitalizations, or quality of life. The authors warn that most AI tools are being deployed on the basis of technical performance rather than demonstrated clinical benefit, raising concerns about the evidence base for clinical AI in routine practice.