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

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