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

PMID: 41276747 · 2025-11-23

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ZeitschriftTherapeutic innovation & regulatory science

Jahr2025-11-23

PMID41276747

Zusammenfassung

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

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