258
▲ 9.8% vs 2024
AI-enabled medical devices authorised by the FDA in 2025; 1,357 in all since 1995
19952025

What the chart shows

The FDA’s list of AI-enabled medical devices includes 258 authorised in 2025, up 9.8% from 235 in 2024 and the most of any year. Annual numbers were in single digits until 2015 and passed 100 in 2020.

The cumulative total reached 1,357 by the end of 2025, after crossing 1,000 in 2024. The AI Index notes that nearly all of these devices reached the market through the 510(k) pathway, which relies on equivalence to existing devices; a study it cites found randomised trial data behind only 2.4% of devices with clinical studies.

Key numbers

MeasureValue
2025258
2024235
2020114
20156
Cumulative, end of 20251,357
Cumulative, end of 20241,099

How to read it

  • Authorised covers every route on the FDA’s AI-enabled device list, mostly 510(k) clearance; the AI Index’s chart title says ‘approved’.
  • The AI Index text says the 258 authorisations of 2025 were counted through September 2025 but gives the cumulative total by December 2025; the data labels both as 2025.
  • The CSV also holds the cumulative series (its second block).
Source: FDA, 2025, via the AI Index Report 2026 (Stanford HAI), figure 6.2.6: Number of AI medical devices approved by the FDA, 1995–2025. Chart and text by AI Adoption.
Numbers checked against the published data on 20 October 2026.
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