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Is the FDA regulation of cardiology AI devices supporting cardiovascular innovation: a scoping review
2
Zitationen
8
Autoren
2025
Jahr
Abstract
While AI/ML technologies are reshaping cardiology, regulatory challenges and reporting transparency impede their optimal use. Strengthened regulatory frameworks, improved trial design and robust post-market surveillance are essential to ensure safety, efficacy and equity in the deployment of AI tools in cardiology.
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