[ Press Release, May 20, 2020 / unofficial translation ] The First Approval of AI-based Cancer Diagnosis Software in Korea - Development of Software that analyzes a presence of prostate cancer using patient’s tissue image - □ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) approved “DeepDx-Prostate,” Korea’s first In Vitro Diagnosis software using AI technology, on April 3. ○ “DeepDx-Prostate,” developed by the Korean medical device company, “Deep Bio Inc.,” is a software using deep learning AI system to learn prostate cancer tissue images. It serves a supplementary role in helping the health professionals diagnose prostate cancer. □ Normally, prostate cancer is diagnosed by a pathology specialist dying prostate the prostate tissue and then observing and reading it in person, using a microscope. - If this software medical device is used, the software analyzes a dyed tissue image, detecting prostate cancer tissue, and thereby it is expected to be a big help in health professionals’ prostate cancer diagnosis. ○ DeepDx-Prostate showed 98.5% of sensitivity and 92.9% of specificity compared to the results from pathology specialists with at least 5 years of experience in clinical trial, which is expected to be highly utilized as supplementary data in on-site medical environment. * Sensitivity: Rate of patients whose test was positive amongst the subjects with the condition * Specificity: Rate of patients whose test was negative amongst patients without the condition. ○ Through the consulting of product briefing session, the MFDS provided the business with technical information such as clinical trial planning and efficacy evaluation methods, and thereby helped make quick approvals possible. □ For reference, the first domestic approval of an AI medical device developed in Korea was made in May 2018 for a product which assesses patient’s bone age, and up till now a total of 20 products from 11 businesses have been approved. □ In line with the 4th Industrial Revolution era, the MFDS expects AI-based product development to become more active in the in vitro diagnostic device area, and has announced an intention to continuously support the quick commercialization of advancing medical devices. 1. Information on Approval of AI-based In Vitro Diagnostic Medical Devices 2. Status of Approved AI Medical Devices Please find the attached file for more information