FDA AI device clearances by year
The busiest year on the FDA AI-device list is 2025, with 335 final decisions. These pages cover every year with at least 10 decisions, from 2016 through 2026. The list itself starts in 1995.
| Year | Devices | Vs prior year | Largest specialty |
|---|---|---|---|
| 2026 (partial) | 181 | In progress | Radiology · 135 |
| 2025 | 335 | +42.6% | Radiology · 254 |
| 2024 | 235 | +4% | Radiology · 183 |
| 2023 | 226 | +39.5% | Radiology · 178 |
| 2022 | 162 | +25.6% | Radiology · 138 |
| 2021 | 129 | +13.2% | Radiology · 110 |
| 2020 | 114 | +42.5% | Radiology · 99 |
| 2019 | 80 | +23.1% | Radiology · 51 |
| 2018 | 65 | +140.7% | Radiology · 40 |
| 2017 | 27 | +50% | Radiology · 16 |
| 2016 | 18 | +200% | Radiology · 11 |
Prior-year percentages compare with the full previous year, including years that are too small for their own page. 2026 is partial through June 29, 2026, so its change versus 2025 is not a finished result. All-time statistics.
Frequently asked questions
Which year had the most FDA AI device clearances?
2025 has the most on the current list, with 335 final decisions.
How many AI devices did the FDA clear in 2026?
The list has 181 AI-device decisions dated 2026, through June 29, 2026. 2026 is still in progress.
Why do some years not have a page?
A year page is published when that year has at least 10 AI-device decisions. The FDA list starts in 1995; smaller early years stay in the all-time statistics.
What date is used for the year?
The FDA date of final decision. A device cleared in December 2025 and updated later still counts in 2025.
Cite as: AI Device Radar, “FDA AI device clearances by year,” https://ai-device-radar.vercel.app/years (FDA list through 2026-06-29).
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