Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a record high of 221 last year, according to data tracing back to 1995. In the first half of this year, the FDA approved 107 AI-powered medical devices, suggesting they were on pace to nearly reach last year’s total.
The FDA classifies each medical device under a particular medical specialty. From the 1990s to mid-2024, radiology devices accounted for about 76% of all AI medical device approvals, far more than the runner-up — cardiovascular — which captured 10% of approvals. Immunology, obstetrics and gynecology, and physical medicine logged the fewest approvals.
As AI innovation surges, medtech companies should consider taking steps to protect their privacy while capitalizing on their intellectual property.
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