Regulatory-approved deep learning/machine learning-based medical devices in Japan as of 2020: A systematic review.

ABSTRACT: Machine learning (ML) and deep learning (DL) are changing the world and reshaping the medical field. Thus, we conducted a systematic review to determine the status of regulatory-approved ML/DL-based medical devices in Japan, a leading stakeholder in international regulatory harmonization. Information about the medical devices were obtained from the Japan Association for the Advancement of Medical Equipment search service. The usage of ML/DL methodology in the medical devices was confirmed using public announcements or by contacting the marketing authorization holders via e-mail when the public announcements were insufficient for confirmation. Among the 114,150 medical devices found, 11 were regulatory-approved ML/DL-based Software as a Medical Device, with 6 products (54.5%) related to rad

SUBMITTER: Aisu N 

PROVIDER: S-EPMC9931274 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature