FDA AI medical device statistics 2026
As of the FDA list updated through June 29, 2026, the FDA has authorized 1,614 AI-enabled medical devices from 653 companies. 335 were authorized in 2025 (+42.6% vs 2024). Radiology accounts for 76.2% of them, and 96.2% went through the 510(k) pathway.
Key statistics
- 1,614 AI-enabled devices are on the FDA list (decisions 1995-09-29 to 2026-06-29).
- 1,268 (78.6%) were authorized in 2021–2026.
- Radiology: 1,230 devices (76.2%).
- Pathways: 510(k) 1,553 (96.2%) · De Novo 40 (2.5%) · PMA 21 (1.3%).
- Top company: Siemens Medical Solutions USA, Inc. with 67 devices. The top 10 companies hold 18.6% of the list.
- 373 companies (57.1%) have exactly one AI device on the list.
- Where openFDA records an applicant country (1,593 devices), 46.3% list the United States.
- Device class (openFDA): Class 2 1,590 · Class 1 2 · Class U 1.
Authorizations per year
2026 is partial (through 2026-06-29).
By specialty
Top 10 companies
Top product codes
Authorizations by year (table)
| Year | Devices | Change | Cumulative |
|---|---|---|---|
| 2026 (partial) | 181 | -46% | 1,614 |
| 2025 | 335 | +42.6% | 1,433 |
| 2024 | 235 | +4% | 1,098 |
| 2023 | 226 | +39.5% | 863 |
| 2022 | 162 | +25.6% | 637 |
| 2021 | 129 | +13.2% | 475 |
| 2020 | 114 | +42.5% | 346 |
| 2019 | 80 | +23.1% | 232 |
| 2018 | 65 | +140.7% | 152 |
| 2017 | 27 | +50% | 87 |
| 2016 | 18 | +200% | 60 |
| 2015 | 6 | 0% | 42 |
| 2014 | 6 | +50% | 36 |
| 2013 | 4 | -20% | 30 |
| 2012 | 5 | +66.7% | 26 |
| 2011 | 3 | +50% | 21 |
| 2010 | 2 | -60% | 18 |
| 2008 | 5 | +400% | 16 |
| 2006 | 1 | 0% | 11 |
| 2005 | 1 | 0% | 10 |
| 2004 | 1 | 0% | 9 |
| 2002 | 1 | -50% | 8 |
| 2001 | 2 | 0% | 7 |
| 1998 | 2 | +100% | 5 |
| 1997 | 1 | -50% | 3 |
| 1995 | 2 | — | 2 |
Browse clearances year by year · Top devices by specialty · Company comparisons
Frequently asked questions
How many AI-enabled medical devices has the FDA authorized?
The FDA's AI-enabled medical device list has 1,614 devices with final decisions from September 29, 1995 to June 29, 2026.
How many AI devices did the FDA authorize in 2025?
335 devices on the list have a final decision dated in 2025, versus 235 in 2024 (+42.6%). 2026 has 181 through June 29, 2026.
Which medical specialty has the most FDA AI devices?
Radiology, with 1,230 devices (76.2% of the list). Next are Cardiovascular (154) and Neurology (73).
Which company has the most FDA AI devices?
Siemens Medical Solutions USA, Inc. has 67, followed by Canon Medical Systems Corporation (42) and Aidoc Medical , Ltd. (35).
What regulatory pathway do most AI medical devices use?
96.2% (1,553) went through 510(k) clearance. The rest: De Novo 40, PMA 21.
Methodology and citation
These figures are computed directly from the FDA's AI-Enabled Medical Devices list, which has 1,614 rows, with fields from openFDA added (applicant, device class, country). Years use the date of final decision. Specialty is the FDA lead review panel. We refresh from the FDA source; last refresh 2026-10-23.
Cite as: AI Device Radar, “FDA AI medical device statistics 2026,” https://ai-device-radar.vercel.app/insights (data through 2026-06-29).
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