FDA-cleared AI: How many devices are cleared by specialty?

Since 1995, the FDA has cleared 521 artificial intelligence-enabled medical devices through 510(k) clearance, de novo requests or approved premarket approval applications, with the majority of cleared devices used in the radiology space, according to a list compiled by biotech company Insilico Medicine, based on information published by the FDA. 

FDA AI device clearances by speciality: 

1. Radiology: 391 devices 

2. Cardiology: 57 devices 

3. Hematology: 15 devices 

4. Neurology: 14 devices 

5. Ophthalmology: eight devices 

6. Clinical chemistry: six devices 

7. Gastroenterology and urology: six devices 

8. Microbiology: five devices 

9. General and plastic surgery: five devices 

10. Pathology: four devices 

11. Anesthesiology: four devices 

12. General hospital: three devices 

13. Obstetrics and gynecology: one device 

14. Dental: one device

Copyright © 2023 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Webinars

Featured Whitepapers

Featured Podcast