Is the FDA regulation of cardiology AI devices supporting cardiovascular innovation: a scoping review.

Journal: Heart (British Cardiac Society)
Published Date: Aug 20, 2025

Abstract

BACKGROUND: Artificial intelligence (AI) and machine learning (ML) have shown immense potential in cardiology, leveraging data-driven insights to enhance diagnosis, treatment planning and patient care. This study presents a comprehensive evaluation of US Food and Drug Administration (FDA)-approved AI/ML devices in cardiology, analysing trends in clinical applications, regulatory pathways and evidence transparency.

Authors

  • Ahmed Hussain
    Department of Cardiology, Queen Elizabeth Hospital, London, UK.
  • Ahmad Guni
    Institute of Global Health Innovation, Imperial College London, London W2 1NY, UK; Department of Surgery and Cancer, Imperial College London, London, UK.
  • Rishikesh Gandhewar
    Glaucoma Research Fellow, Moorfields Eye Hospital, London, UK.
  • John Warner-Levy
    The University of Manchester, Manchester, UK.
  • Alexander Davidson
    Imperial College London Institute of Global Health Innovation, London, UK.
  • Kamal Shah
    Institute of Pharmaceutical Research (IPR), GLA University Mathura, NH-2 Delhi Mathura Road, Po Chaumuhan, Mathura, Uttar Pradesh 281406, India.
  • Ara Darzi
    Imperial College London London UK.
  • Hutan Ashrafian
    Institute of Global Health Innovation, Imperial College London, London, United Kingdom.

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