Regulatory Challenges and Opportunities: A Review of U.S. Food and Drug Administration-Approved Artificial Intelligence and Machine Learning-Enabled Cardiovascular Devices.

Abstract

The integration of artificial intelligence (AI) and machine learning (ML) into medical devices has revolutionized healthcare, enhancing diagnostic accuracy and clinical decision-making. However, their rapid evolution poses challenges to traditional regulatory frameworks, particularly in ensuring safety and effectiveness. This review examines current Food and Drug Administration (FDA) regulatory pathways for AI/ML-enabled cardiovascular medical devices. It assesses the pre- and postmarket criteri