Concepts in U.S. Food and Drug Administration Regulation of Artificial Intelligence for Medical Imaging.

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.