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FDA Publishes List of Approved AI/ML-Enabled Medical Devices

The U.S. Food and Drug Administration (FDA) has published its first list of authorized medical devices incorporating software based on artificial intelligence (AI) and machine learning (ML) technologies.

Posted to its website, the FDA’s list of AI/ML-enable medical devices provides detailed submission information on nearly 350 separate medical devices that have been reviewed and authorized by the agency under its 510(k), De Novo, or PMA routes.

AI/ML-enabled medical devices have the potential to generate significant amounts of healthcare data, which can be used by healthcare providers and researchers to improve the delivery of healthcare and improve patient outcomes. The FDA says that its release of the list of authorized devices provides both industry and the general public with important information on innovations and developments in this growing segment of the medical device industry.

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Read the FDA’s list of AI/ML-enabled medical devices is available on the FDA’s website.

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