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FDA has now cleared more than 500 healthcare AI algorithms

Updated: Jul 31, 2023

There are now more than 520 marker-cleared artificial intelligence (AI) medical algorithms available in the United States, according to the U.S. Food and Drug Administration (FDA) as of January 2023. The vast majority of these are related to medical imaging.

Here is the breakdown for the number of FDA-cleared algorithms across specialties:


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