Clinical Application of EndoBRAIN, a Medical Device Adopting Artificial Intelligence: Challenges to Obtain Regulatory Approval and Insurance Reimbursement

Abstract

EndoBRAIN (Cybernet System Corp.; Olympus Corp., Tokyo) is the computer-aided diagnostic system supportedby artificial intelligence (AI) that allows real-time identification of colorectal polyps. EndoBRAIN was the firstly approved medical device in the field of AI in Japan. This regulatory approval was achieved by the close collaboration among medical researchers, engineering researchers, industrial partners, and public funding bodies. This review article shows the overview of EndoBRAIN including its design, performance, and results in clinical trials. In addition, our approaches to regulatory approval and insurance reimbursement, which unfortunately has not been granted, are also introduced.