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PubMed

Growth, Specialty Distribution, and Regulatory Pathways of Artificial Intelligence-Enabled Medical Devices Authorized in the United States From 1995 to 2026: A Cross-Sectional Analysis.

PMID: 42985596 ·

S, u, h, a, i, l, , S, , A, l, s, h, a, h, r, a, n, i

JournalCureus
Year
PMID42985596

Abstract

Introduction The United States Food and Drug Administration (FDA) publishes a list of artificial intelligence (AI)-enabled medical devices authorized for marketing. Annual authorizations have risen sharply in recent years, and an updated analysis of the complete list is needed. This study aimed to characterize regulatory authorizations on the full list through mid-2026. Methods A cross-sectional analysis of all 1,614 entries on the FDA AI-Enabled Medical Device List (final decisions from Septemb

Official Source

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