The Food and Drug Administration (FDA) has published a list of medical devices incorporating artificial intelligence (AI) and machine learning (ML) which are authorized for marketing in the United States. The potential benefit of ML for medical devices is the potential for product improvement resulting from data generated during delivery of health care. The devices have been authorized through 510(k) clearance, De Novo request, or premarket approval (PMA). This initial list includes 343 entries and is searchable. The FDA states it plans to update the list periodically.

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