10 companies with the most FDA-cleared AI medical devices

Since 1995, the FDA has cleared 521 artificial intelligence-enabled medical devices through 510(k) clearance, de novo requests or approved premarket approval applications. 

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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

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