Surge in FDA-Approved AI Medical Devices Signals a New Era in Healthcare Innovation

The number of FDA-authorized medical devices using artificial intelligence (AI) has surged over the past decade, reaching 950 as of August 7, 2024. While the first AI-enabled device was approved in 1995, growth has accelerated since 2015, driven by advances in connectivity, increased investment, and a better understanding of software regulation in healthcare. In 2023…

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