Healthcare

5 takeaways from the FDA’s updated list of cleared AI/ML medical devices

Medtech Dive, 10/24/23. The Food and Drug Administration (FDA) has updated its list of AI/ML-enabled medical devices, revealing that nearly 700 devices have received marketing authorization. The majority of the newly cleared devices were in the field of radiology. The rate of FDA submissions for these devices has been increasing every year since 2015, with a significant increase seen between 2019 and 2020. GE HealthCare and Siemens Healthineers led the list with the most authorized devices. Interestingly, none of the cleared devices on the list used generative AI or artificial general intelligence. The majority of devices went through the FDA’s 510(k) pathway for clearance, while only a few received de novo clearance. READ THE ARTICLE