60
▲ 8.6× since 2016
AI-enabled devices outside radiology authorised by the FDA in 2025; radiology had 198
20162025

What the chart shows

Outside radiology, the FDA authorised 60 AI-enabled medical devices in 2025, up from 7 in 2016 and 52 in 2024. Cardiovascular devices led with 20, followed by neurology (15) and other specialties (11).

Neurology rose from 2 in 2022 to 15 in 2025, and anaesthesiology has had 5 a year since 2023. Radiology grew faster in absolute terms, from 11 in 2016 to 198 in 2025, so its share of each year’s authorisations is higher than in 2016 (related chart).

Key numbers

MeasureValue
Outside radiology, 202560
Outside radiology, 202452
Outside radiology, 20167
Cardiovascular, 202520
Neurology, 202515
Radiology, 2025198

How to read it

  • Radiology is left out so the other specialties are visible; its yearly counts are in the CSV.
  • Other covers specialties beyond the five named, such as ophthalmic and pathology devices.
  • Authorised covers every route on the FDA’s list, mostly 510(k) clearance; the AI Index’s chart title says ‘approved’.
Source: FDA, 2025, via the AI Index Report 2026 (Stanford HAI), figure 6.2.8: Number of AI/ML medical devices approved by the FDA by specialty, 2016–25. Chart and text by AI Adoption.
Numbers checked against the published data on 20 October 2026.
Download the data (CSV) · Cite this chart