Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use.

Journal: JAMA network open
PMID: 40305017

Abstract

IMPORTANCE: The primary objective of any newly developed medical device using artificial intelligence (AI) is to ensure its safe and effective use in broader clinical practice.

Authors

  • Daniel Windecker
    Department of Diagnostic and Interventional Neuroradiology, University of Bern, Bern, Switzerland.
  • Giovanni Baj
    Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland.
  • Isaac Shiri
    Biomedical and Health Informatics, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.
  • Pooya Mohammadi Kazaj
    Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.
  • Johannes Kaesmacher
    Institute of Diagnostic and Interventional Neuroradiology, Institute of Diagnostic, Interventional and Pediatric Radiology and Department of Neurology, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland.
  • Christoph Gräni
    Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • George C M Siontis
    Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

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