AI Medical Software Assisting Diagnosis, Accelerating Medical Device Approval Process

Ministry of Science and ICT and MFDS Hold 'Doctor Answer' Meeting at Asan Medical Center

[Asia Economy Reporter Choi Dae-yeol] The government has decided to accelerate the approval of software (SW) that uses artificial intelligence (AI) technology to predict the risk of colorectal polyps or to diagnose dementia early as medical devices.

The Ministry of Science and ICT and the Ministry of Food and Drug Safety held a meeting on the 31st at Seoul Asan Medical Center to discuss ways to expedite the approval of the AI medical SW 'Doctor Answer.' The Doctor Answer project team, led by Kim Jong-jae, Director of the Asan Institute for Life Sciences at Seoul Asan Medical Center (Professor of Pathology), has been developing the software since 2018 with the participation of 1,962 people from 26 domestic medical institutions and 22 information and communication technology companies.

The goal is to assist in prediction or diagnosis in medical settings for eight major diseases including cancer, cerebrovascular and cardiovascular diseases, heart disease, dementia, epilepsy, and rare pediatric genetic disorders. Currently, 21 types of SW incorporating AI technology are undergoing clinical trials at 37 domestic medical institutions.

So far, four types of SW, including diagnosis of cerebral hemorrhage or coronary artery calcification scores, colon polyp analysis based on endoscopic image analysis, and automatic segmentation of brain imaging metrics, have received medical device approval from the Ministry of Food and Drug Safety. Seven others related to prostate cancer?covering staging, recurrence, survival prediction, histopathology and imaging-based diagnosis, early dementia diagnosis, and quantitative analysis of normal brain waves?are currently under approval review.

Five types are classified as non-medical devices, and the remaining five are in prototype development. During the meeting, the current status of clinical trials and pilot applications for specific diseases were presented, along with discussions on ways to expedite future approvals. Efforts to enter overseas markets were also planned, including cross-validation at six national hospitals in Saudi Arabia.

Yang Jin-young, Deputy Director of the Ministry of Food and Drug Safety, said, "In 2017, we created the world's first approval review guidelines for medical devices applying AI technology," adding, "We will support Doctor Answer to receive medical device approval swiftly." Jang Seok-young, 2nd Vice Minister of the Ministry of Science and ICT, said, "We will help Doctor Answer, which plays a key role in the Digital New Deal project, provide high-quality medical services both domestically and internationally."