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

Abstract

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