PubMed

Is the FDA regulation of cardiology AI devices supporting cardiovascular innovation: a scoping review.

PMID: 40835433 · 2026-02-23

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ЖурналHeart (British Cardiac Society)

Год2026-02-23

PMID40835433

Аннотация

Artificial intelligence (AI) and machine learning (ML) have shown immense potential in cardiology, leveraging data-driven insights to enhance diagnosis, treatment planning and patient care. This study presents a comprehensive evaluation of US Food and Drug Administration (FDA)-approved AI/ML devices in cardiology, analysing trends in clinical applications, regulatory pathways and evidence transparency. FDA clearance summaries from the AI/ML medical device database were reviewed to identify cardi

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