~76%
of authorised AI devices are radiology
What the research found
The FDA's official list shows roughly 1,451 authorised AI/ML devices by end-2025, with about 76% in radiology. The concentration reflects where digital data is abundant, not where clinical need is greatest.
Why it matters for providers
AI is entering medicine unevenly, driven by data availability rather than patient priority — and the hardest decisions aren't where the tools are.
Original source
U.S. FDA — AI/ML-enabled device list
Peer-reviewed or official source — the most reliable tier.