FDA on track to clear 1,000+ clinical AI algorithms by end of the year

HealthExec August 13, 2024
Dave Fornell

The number of clinical artificial intelligence (AI) algorithms cleared by the U.S. Food and Drug Administration (FDA) is on track to surpass an all-time total of 1,000—and that figure only includes AI used in patient care. As of writing, the agency has approved 950 different AI algorithms since beginning the process in 1996, according to its internal data last updated July 2024.

In 2024 alone, the FDA has already approved 107 algorithms.

In 1996 when the FDA began approving AI for clinical use, only 33 models were cleared over the 20 years that followed. The numbers of AI approvals exploded in 2016, then began growing exponentially each year after.

Medical imaging dominates

Radiology has been the clear leader, well ahead...

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