FDA AI Radiology: Zero Clinical Proof

Of 1,357 AI devices cleared by the FDA, only three were tested against what patients actually care about: survival, readmission, quality of life.

1,357 AI and machine learning devices cleared by the FDA. Over a thousand tools now deployed in hospitals, clinics, and radiology departments across the country. Cleared. Approved. Covered.

And only three of them - three - were ever tested against what patients actually care about: whether they lived, recovered, avoided a readmission, or got back to their lives.

That is not a gap in the evidence. That is a canyon.

A new study published in PLOS Digital Health (Abulibdeh et al., University of Toronto, August 2026) tore back the curtain on the evidence base for AI in medicine. The numbers are worse than I expected, and I work in this space every single day.

The Study Nobody Is Talking About

The researchers examined all 1,357 AI/ML-enabled medical devices cleared by the FDA through December 5, 2025. They cross-referenced those devices against ClinicalTrials.gov, PubMed, and the FDA AI-Enabled Device List (which now stands at 1,524 entries as of March 2026).

Here is what they found:

• Only 34 devic…