Analysis: FDA's AI device list holds 1,430 authorized devices for 1995–2025
A longitudinal content analysis in the Journal of Medical Internet Research examined all 1,430 devices in the FDA's list of AI- and machine-learning-enabled devices, based on data downloaded on 1 March 2026. The study tracks expansion across clinical specialties from 1995 to 2025.
Who is affected and how
- medtech company
- The specialty distribution shows which clinical areas are crowded or still empty in the AI device market.
- health policy
- The registry analysis provides data for regulatory monitoring of how AI devices spread across specialties.
Sources
- Journal of Medical Internet Research - Clinical Specialty Expansion of AI-Enabled and Machine Learning–Enabled Medical Devices Authorized by the US Food and Drug Administration From 1995 to 2025: Longitudinal Content Analysisdoi.org · Aug 25, 2026
- Food And Drug Administration - Vegan Freaksveganfreaks.net · Aug 27, 2026
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