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