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Toward standardized premarket evaluation of computer aided diagnosis/detection products: insights from FDA-approved products

Wang, L; Wang, H; Xia, C; Wang, Y; Tang, QH; Li, JG; Zhou, XH

Li, JG (corresponding author), Natl Inst Food & Drug Control, Beijing, Peoples R China.; Zhou, XH (corresponding author), Peking Univ, Beijing Int Ctr Math Res, Sch Publ Hlth, Dept Biostat, Beijing, Peoples R China.

EXPERT REVIEW OF MEDICAL DEVICES, 2020; 17 (9): 899

Abstract

Introduction Computer aided detection and diagnosis (CADe and CADx) products are an emerging branch of medical device industry. However, limited techn......

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