AIDOT Co., Ltd. (CEO Jaehoon Jung) announced on the 23rd that its AI-based urinary stone detection and diagnostic support software, ‘URO dot AI’, has been designated as Innovative Medical Device (Integrated-General No. 81) by the Ministry of Food and Drug Safety (MFDS). This solution is the result of over three years of joint research with Professor Jaewon Oh’s team from the Emergency Medicine Department of Hanyang University, Professor Donggun Lee’s team from the Emergency Medicine Department of Seoul National University Bundang Hospital, and Professor Sungyong Cho’s team from the Department of Urology at Seoul National University, all under the support of a NIPA (National IT Industry Promotion Agency) project. With this designation, the world’s only “URO dot AI” solution can now be officially used in Korea as a non-reimbursed (uninsured) item in clinical settings. According to company officials, URO dot AI analyzes CT images to detect stones in the kidney, urinary tract, and bladder, and accurately displays the size and location of detected stones to assist medical professionals with diagnosis. Even for emergency urolithiasis cases, it can quickly and accurately identify the location of urinary stones, and can detect stones as small as 0.7mm with a sensitivity of 97.89%, providing significant assistance for prognosis management of urinary stone patients. Urolithiasis is a condition where stones form in the urinary tract, causing severe flank pain. Given its genetic association, ongoing follow-up is important. According to the Health Insurance Review and Assessment Service, more than 300,000 people annually in Korea are treated for urinary stones, with cases increasing across all age groups. AIDOT CEO Jaehoon Jung stated, “We will continue our efforts to contribute to public health by collaborating with Korea’s top medical professionals, researching not only X-ray-based AI urinary stone detection systems but also AI diagnostic support solutions for urologic diseases.” He added, “Currently, AIDOT’s ‘URO dot AI’ is the only product that can be claimed as a non-reimbursed item in Korea, and as we enter this market, we expect a sharp increase in domestic sales.” 

Korea Economic TV / 2025.01.23 / Deputy Director Yang Jae-jun