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New FDA Web Page Spotlights AI/ML Progress

The US agency has published a list of more than 300 artificial intelligence/machine learning devices it has allowed on the market, highlighting the work it has done to review these new and complicated products.

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The US Food and Drug Administration has published a new web page with an ongoing list of artificial intelligence/machine learning-enabled (AI/ML) products that it has reviewed and allowed on the market. The site showcases the work the agency has put in to get such products to the public, especially considering their novelty and complexity.

The agency on 22 September published the page that lists 343 entries for various AI/ML products that have received 510(k) clearance, premarket approval (PMA) or de novo authorization. It goes as far back as 1997 with the 510(k) clearance of the Compumedics Sleep Monitoring System

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