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PubMed

Development and Commercialization Pathways of AI Medical Devices in the United States: Implications for Safety and Regulatory Oversight.

PMID: 42932597 ·

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JournalNEJM AI
Year
PMID42932597

Abstract

AbstractThe landscape of U.S. Food and Drug Administration-regulated artificial intelligence-enabled medical devices (AIMDs) has expanded rapidly, with clearances and authorizations increasing, on average, from 1.4 to 146 per year (1995 through 2014 vs. 2020 through 2024, respectively). In this review of 950 AIMDs and their associated commercialization trends, private firms comprise 68.9% of the manufacturers, yet public companies produce more devices per firm on average (5.1 vs. 2.0), reflectin

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