Only three of 1,357 FDA-authorized AI medical devices were evaluated on patient outcomes
A PLOS Digital Health evidence census linked the FDA's 1,357 authorized AI and machine-learning medical devices through December 5, 2025 to prospective trials and publications. Thirty-four devices were linked to registered prospective trials, 12 had posted results, 12 had peer-reviewed publications, and only three evaluated patient-centered outcomes such as mortality, morbidity, or readmission. The review does not show that the remaining devices are ineffective; it shows that authorization and benchmark performance rarely answer the outcome question patients care about most. With 78 percent of the devices concentrated in radiology and vulnerable populations often excluded from studies, the validation gap can travel through hospitals and across countries long before durable benefit or equitable performance is known.
