Since 1995, the FDA has cleared 521 artificial intelligence-enabled medical devices through 510(k) clearance, de novo requests or approved premarket approval applications.
There are 10 companies with more than one AI-enabled device cleared by the FDA, according to a list compiled by biotech company Insilico Medicine, based on information published by the FDA.
Ten companies with the most cleared AI medical devices:
1. GE: 42 devices
2. Siemens: 29 devices
3. Canon: 17 devices
4. Aidoc: 13 devices
5. Philips: 10 devices
6. Zebra Medical Vision (acquired by Nanox Vision): nine devices
7. Quantib: seven devices
8. Shanghai United Imaging Healthcare: six devices
9. Viz.ai: six devices
10. Arterys (acquired by Tempus Labs): six devices