Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products.

Abstract

Authors

• Tomohiro Kikuchi
  Department of Radiology, Jichi Medical University, Tochigi, Japan.
• Shannon L Walston
  Department of Diagnostic and Interventional Radiology, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
• Hirotaka Takita
  Department of Diagnostic and Interventional Radiology, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
• Yasuhito Mitsuyama
  Department of Diagnostic and Interventional Radiology, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
• Rintaro Ito
  Department of Innovative Biomedical Visualization, Nagoya University Graduate School of Medicine, Showa-ku, Nagoya, Japan.
• Masahiro Hashimoto
  Department of Radiology, Keio University School of Medicine, Tokyo, Japan. [email protected].
• Takeshi Nakaura
  Department of Diagnostic Radiology, Graduate School of Medical Sciences, Kumamoto University, Honjo 1-1-1, Kumamoto 860-8556, Japan (T.N., N.Y., N.K., Y.N., H.U., M.K., S.O., T.H.). Electronic address: [email protected].
• Hiroaki Hyakutake
  Medical AI Promotion Institute Co., Ltd., Life Science Building, 12-9 Nihonbashi Odemmachi, Chuo-ku, Tokyo, Japan.
• Sho Kawabe
  Medical AI Promotion Institute Co., Ltd., Life Science Building, 12-9 Nihonbashi Odemmachi, Chuo-ku, Tokyo, Japan.
• Harushi Mori
• Daiju Ueda
  Department of Diagnostic and Interventional Radiology, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan. [email protected].

Keywords

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