US regulators have cleared 1,614 medical devices that use AI, most of them to read scans
The FDA's list counts 1,614 AI devices since 1995, 335 of them in 2025 alone. In one study of 903 such devices, 4.8% were later recalled.
AI-enabled medical devices authorised in the US
Running total of devices on the FDA's own list of AI-enabled medical devices, by the year the agency made its final decision.
What this measures: A medical device can only be sold in the United States after the FDA clears or approves it. The agency publishes a list of the ones that use artificial intelligence. Most are software that reads medical scans, not chatbots.
The last point covers only the first half of 2026. The FDA's list ran to decisions made up to 29 June 2026 when it was last updated on 4 September 2026, so the 2026 total will rise.
Counted from the FDA's CSV of the list (file dated 4 September 2026): 1,614 authorisations. 1,553 used the 510(k) route, which asks whether a device matches one already on the market, and 1,230 are radiology devices. Some products appear more than once as later versions were authorised (1,317 distinct device names from 817 companies). The FDA says the list is not comprehensive.
Show data table and sources
| Date | Label | Value |
|---|---|---|
| 31 Dec 2010 | 18 devices | |
| 31 Dec 2013 | 30 devices | |
| 31 Dec 2015 | 42 devices | |
| 31 Dec 2016 | 60 devices | |
| 31 Dec 2017 | 87 devices | |
| 31 Dec 2018 | 152 devices | |
| 31 Dec 2019 | 232 devices | |
| 31 Dec 2020 | 346 devices | |
| 31 Dec 2021 | 475 devices | |
| 31 Dec 2022 | 637 devices | |
| 31 Dec 2023 | 863 devices | |
| 31 Dec 2024 | 1,098 devices | |
| 31 Dec 2025 | 1,433 devices | |
| 29 Jun 2026 | 1,614 devices | 1,614 devices |
- List of Artificial Intelligence-Enabled Medical Devices (US Food and Drug Administration)
- AI-enabled medical devices list (CSV download) (US Food and Drug Administration)
- Clinical Evidence and FDA Recalls of Artificial Intelligence-Enabled Medical Devices (JAMA Network Open via PubMed)
A medical device can only be sold in the United States once the FDA has cleared or approved it, and the agency keeps a public list of the ones that use AI. The file we downloaded on 9 November 2026, last updated by the FDA on 4 September 2026, holds 1,614 entries. The oldest is a cervical-screening system cleared in September 1995.
This is mostly image analysis, not chatbots. 1,230 of the entries are radiology devices, 154 cardiovascular and 73 neurology. The FDA says it is still working out how to spot devices that contain large language models, so the list does not separate those out yet.
The pace has changed sharply. By the end of 2015 there were 42 authorisations in total. 335 came in 2025 alone, the highest for any full year, taking the running total to 1,433. Another 181 followed in the first half of 2026, up to 29 June.
Being cleared is not the same as working well in a hospital. A study in JAMA Network Open in June 2026 followed 903 of these devices, cleared between 1995 and August 2024. 43 of them (4.8%) were recalled, after a median of 458 days on the market. Devices whose public summaries said nothing about clinical studies looked more likely to be recalled, but the estimate was too uncertain to be sure.
What it means
AI is already in routine US medical care, mainly as software that flags things on a scan for a doctor to check. What the list does not tell you is whether any of it helps patients: clearance often means a device resembles one already on sale, not that it was tested in a trial. If you are offered a scan read with AI, the useful question is what evidence exists for that specific device.
Caveats
- Nothing here measures patient outcomes. For that you need trials, like the breast-screening results from Sweden and Germany covered separately on this site.
- The FDA says the list “is not a comprehensive resource” and that devices were found mainly by looking for AI-related terms in authorisation summaries, so both over- and under-counting are possible.
- Each row is a submission, not a distinct product. The 1,614 rows carry 1,317 different device names from 817 companies, because updated versions are authorised again.
- 1,553 of the 1,614 went through the 510(k) route, which asks whether a device is substantially equivalent to one already on sale rather than requiring a new clinical trial. Only 21 came through premarket approval, the strictest route.
- The 2026 figure is a part year. The list also lags: the FDA adds devices in a later update when their decision summaries were not published in time.