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FDA-reviewed artificial intelligence-enabled products applicable to emergency medicine
Jacob Morey1, John Schupbach1, Derick Jones1
1Department of Emergency Medicine, Mayo Clinic, Rochester, MN, USA.
The American Journal of Emergency Medicine
|January 4, 2025
Summary
Artificial intelligence (AI) products are increasingly regulated by the FDA. Of 610 unique AI products, 154 are applicable to emergency medicine (EM), mostly for diagnostic imaging assistance.
Area of Science:
- Medical Informatics
- Emergency Medicine
- Regulatory Science
Background:
- Artificial intelligence (AI) is rapidly advancing, leading to a growing number of AI-enabled products.
- The U.S. Food and Drug Administration (FDA) regulates these AI products, impacting their clinical integration.
Purpose of the Study:
- To identify and evaluate AI-enabled products approved by the FDA for potential use in emergency medicine (EM).
- To assess the net health benefit of AI products applicable to EM practice.
Main Methods:
- Systematic review of FDA-marketed AI products as of March 2024.
- Analysis by board-certified EM physicians to determine applicability to acute care settings.
- Evaluation of net health benefit using the ICER Evidence Rating Matrix.
Main Results:
- Out of 610 unique AI products reviewed by the FDA, 154 (25%) were found applicable to EM.
- The majority of applicable products were approved via Radiology, Cardiovascular, and Neurology panels.
- 30 products demonstrated comparable or incremental net health benefit (C+ rating).
Conclusions:
- The FDA is approving an increasing number of AI-enabled products.
- A significant portion of these AI products have direct applications in emergency medicine, particularly for diagnostic support.
- Opportunities exist for EM physicians to contribute to AI product review and clinical implementation.
