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

Becker's Healthcare February 7, 2023
Claire Wallace

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

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