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# FDA authorisations of AI devices outside radiology rose from 7 in 2016 to 60 in 2025
- URL: https://aiadoption.org/data/fda-ai-devices-outside-radiology/
- Published: 2026-10-19T16:36:25.000Z
- Updated: 2026-10-21T06:04:59.000Z
- Description: The FDA authorised 60 AI-enabled devices outside radiology in 2025, up from 7 in 2016. Cardiovascular (20) and neurology (15) led; radiology alone had 198.
- Author: Manu
- Tags: Data, AI in Healthcare, AI in the US, #chart, #ai-index-2026, #hub-healthcare, #country-us

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](https://aiadoption.org/data/fda-ai-medical-devices-per-year/)).

## Key numbers

| Measure                 | Value |
| ----------------------- | ----- |
| Outside radiology, 2025 | 60    |
| Outside radiology, 2024 | 52    |
| Outside radiology, 2016 | 7     |
| Cardiovascular, 2025    | 20    |
| Neurology, 2025         | 15    |
| Radiology, 2025         | 198   |

## 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](https://aiadoption.org/sources/#fda-ai-devices), 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)](https://charts.aiadoption.org/ai-index/csv/fda-ai-devices-outside-radiology.csv?ref=aiadoption.org) · [Cite this chart](#source)