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This paper is in the following e-collection/theme issue:

Artificial Intelligence (4758) Clinical Information and Decision Making (3697) Adoption and Change Management of eHealth Systems (1115) mHealth in a Clinical Setting (1144) Machine Learning (3167) Development of Novel Medical Devices and Innovations for Existing Devices (152) Regulatory Issues and Medical Device Certification (12)

Published on in Vol 28 (2026)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/103040, first published .
Medical professionals analyze AI-driven brain scan, heart ultrasound, and patient data.

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 Analysis

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 Analysis

Authors of this article:

Youn-Soo Lee1 Author Orcid Image ;   Bo-Young Youn1, 2 Author Orcid Image
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Youn-Soo Lee   1 ;   Bo-Young Youn   1, 2 , MPH, MBA, PhD

1 Department of Digital Healthcare, College of Health and Medical Science, Daejeon University, Daejeon, Republic of Korea

2 Department of Healthcare Management, College of Health and Medical Science, Daejeon University, Daejeon, Republic of Korea

Corresponding Author:

  • Bo-Young Youn, MPH, MBA, PhD
  • Department of Healthcare Management
  • College of Health and Medical Science, Daejeon University
  • #505 Moonmugwan 62, Daehak-ro, Dong-gu
  • Daejeon 34520
  • Republic of Korea
  • Phone: +82-42-280-2062
  • Email: jmyoun07@daum.net