4.5 Article

Concepts in US Food and Drug Administration Regulation of Artificial Intelligence for Medical Imaging

Journal

AMERICAN JOURNAL OF ROENTGENOLOGY
Volume 213, Issue 4, Pages 886-888

Publisher

AMER ROENTGEN RAY SOC
DOI: 10.2214/AJR.18.20410

Keywords

artificial intelligence; Food and Drug Administration

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OBJECTIVE. Although extensive attention has been focused on the enormous potential of artificial intelligence (AI) technology, a major question remains: how should this fundamentally new technology be regulated? The purpose of this article is to provide an overview of the pathways developed by the U.S. Food and Drug Administration to regulate the incorporation of AI in medical imaging. CONCLUSION. AI is the new wave of innovation in health care. The technology holds promising applications to revolutionize all aspects of medicine.

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