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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.
Objective:
To identify and assess artificial intelligence (AI)-enabled products reviewed by the U.S. Food and Drug Administration (FDA) that are potentially applicable to emergency medicine (EM).
Methods:
The FDA AI-enabled products website was accessed to identify all marketed products as of March 2024. Board-certified EM physicians analyzed all products for applicability to EM practice. Inclusion criteria included products used by EM physicians directly or non-EM physicians participating directly in the evaluation and management of patients in an acute care setting. The Clinical and Economic Review (ICER) Evidence Rating Matrix was used to rate the net health benefit of applicable products.
Results:
A total of 882 AI-enabled products have been reviewed by the FDA from 1995 to 2024. There were 272 products that were updates of prior products that were excluded, leaving 610 unique products. Products were most commonly evaluated by Radiology (454/610), Cardiovascular (59/610), and Neurology (25/610) panels. We found 154 (25 %) products applicable to EM that were approved through Radiology (121/154), Cardiovascular (24/154), Neurology (5/154), Anesthesiology (3/154), and Ophthalmology (1/154) panels. There were 30 products that were rated as having a comparable or incremental net health benefit with moderate certainty (a C+ rating).
Conclusion:
An increasing number of AI-enabled products are available and regulated by the FDA. We have identified 154 that are applicable to EM, primarily related to assisting with diagnosis on various imaging modalities. There remain many opportunities for EM to assist in product reviews and meaningful translation of products into clinical practice.
