- Statistics
FDA-cleared AI devices, 2026 report
How the FDA list of AI-enabled devices grew, by year and specialty, and how to read a clearance.
PDF · 12 pages · Updated 30 September 2026
- Who it is for
- Anyone who cites the FDA list of AI-enabled devices, or has to read a clearance before buying.
- Format
- Length
- 12 pages
- Updated
- 30 September 2026
- Topic
- Statistics
Three findings inside
1,430
AI-enabled devices on the FDA list with final decisions through 31 December 2025.
FDA AI-Enabled Medical Device List, via Lee and Youn, JMIR, 2026
76.5%
of them, 1,094 devices, are in radiology, ahead of cardiovascular (136) and neurology (65).
FDA AI-Enabled Medical Device List, as downloaded 1 March 2026
29.2%
of machine-learning devices authorized in 2024 reported both sensitivity and specificity.
Almarie et al., Biomedicines, 2025
What is inside
- How fast the list is growing
- Which specialty owns the list
- What the cleared devices actually do
- Which pathways and sponsors dominate
- Change-control plans
- How transparent the summaries are
- How to read a clearance, field by field
- Where the rules are heading
Get it
How the FDA list of AI-enabled devices grew, by year and specialty, and how to read a clearance.
PDF · 12 pages. The download starts on this page and the file is also sent to your inbox.
Read the guides behind it
Questions
Is this clinical or regulatory advice?
No. It appraises published evidence and sources. Confirm anything that affects a patient or a purchase with your own governance team and counsel.
Do I have to join the briefing to download?
No. The download does not depend on the box. The box is only for the AIMOCS briefing, and nothing is sent until you confirm from the email we send you.
What do you do with my email address?
We use it to send you this file. The privacy notice says what else we do, and how to ask us to delete it.
Physicians and teams working on AI in healthcare
Meet them in the network.
FDA-cleared AI devices, 2026 report
Get it