Jaehoon Jung, CEO of AIDOT 3D training with CT images greatly improves surgical precision Commercialization possible after clinical trials are completed in the first half of next year Preparing an “all-in-one lithotripter” with built-in AI The medical AI company AIDOT Inc. has developed new equipment for the treatment of urinary stones. Over a two-year collaboration with Hanyang University Hospital and Bundang Seoul National University Hospital, the company developed a medical AI device, “URO dot AI,” that pinpoints the location and size of urinary stones in the kidneys, ureters, and bladder. AIDOT CEO Jaehoon Jung met with The Medical at the AIDOT office in Songpa-gu, Seoul, on December 13, 2023, and stated, “This is the world’s first medical device that pinpoints the size and location of stones using AI.” He added, “This solution uses CT-based images to provide highly sensitive and specific analysis. After two years of development, URO dot AI has reached its final form and can now be utilized as diagnostic support software at hospitals equipped with CT imaging.” He also added, “It provides physicians with an easy-to-use client reading interface and is evaluated as a model that can be commercialized immediately once regulatory approval is obtained.” URO dot AI was developed as part of a project supported by the Ministry of Science and ICT for AI-based medical imaging interpretation systems, specifically for building big data for urinary tract stone patients and developing/testing an AI support system for clinical decisions and insurance claims. Urinary stones are usually treated with a shock wave lithotripter, and insurance is applied for stones larger than 4mm in diameter. Smaller stones can be naturally excreted via urine, but larger stones can cause severe pain and cannot pass naturally, so the 4mm threshold is critical for insurance. Previously, doctors had to manually check CT images one by one to determine stone size, which was time-consuming, labor-intensive, and prone to error. Now, AI can instantly and automatically analyze all images and detect stones, greatly improving the process. AIDOT has submitted its clinical trial protocol for URO dot AI to the Ministry of Food and Drug Safety (MFDS). The MFDS will examine whether the device accurately pinpoints stone size and location and whether it can be implemented in clinical settings. AIDOT expects the clinical trials to be completed and regulatory approval granted in the first half of next year. CEO Jung confidently stated, “We can detect the location of stones with a diameter of 4mm or more with 96.51% accuracy, and even find stones as small as 0.7mm.” Since these very small stones (0.7mm) can be detected, identifying 4mm stones is easy for URO dot AI. The key was training the AI to process 3D CT images, a task started in 2022 and completed in early 2023. In 2024, AIDOT plans to launch research into an X-ray based version of URO dot AI. CEO Jung explained, “Current lithotripters mainly use X-rays to locate and size stones, but low-cost units aren’t precise—if the device misses the stone, it can damagingly hit other organs such as kidneys. There has even been litigation due to such issues.” He emphasized, “Detecting the exact location and size of stones is critically important.” If the X-ray-based URO dot AI can be integrated into lithotripters, such medical accidents can be prevented. CEO Jung explained, “The pain caused by stones is said to be 10 times worse than labor pain. Patients are terrified of recurrence or unsure whether the stones have been completely shattered. Because stones may be hereditary and recur, regular preventative exams are necessary, but current devices using X-rays have limitations. With URO dot AI, patients will have accurate records and can track their own treatment, ensuring reliable after-service. This will avoid the current situation of endless expense, continued pain, and repeated X-ray exposure. It will help reduce unnecessary treatment and healthcare costs caused by uncertain diagnoses and wasted procedures.” He continued, “In 2024, we plan to start joint research with H&T Medical to develop an all-in-one shock wave lithotripter with built-in X-ray-based URO dot AI. URO dot AI is especially effective at detecting stones in the 2mm-wide ureter.” The AI, trained on kidney, ureter, bladder, and urethra images, can detect stones that humans may miss. He predicted, “When the ‘AIDOT all-in-one’ is released, it will be as disruptive globally as our Cerviray system.” He also said, “After regulatory approval, with patient consent, URO dot AI will help build big data through prospective studies.” Founded in 2014, AIDOT developed Cerviray, a cervical cancer diagnostic support solution (approved as a Class III medical device in Korea), now used in 180 hospitals across 18 countries, saving lives in Southeast Asia, Africa, and South America where awareness and resources for cervical cancer are low. CEO Jung noted, “In these areas, lack of cervical cancer awareness means many women go undiagnosed and die unknowingly, with daily averages such as 14 deaths in Indonesia and 20 in the Philippines. Korea was like this in the 1970s and 1980s.” Jung has a background in IT planning at Interpark, Yahoo Korea, and later managed an AR mobile gaming company before founding AIDOT in 2014. Inspired by applying image-processing technology to cervical cancer diagnostics, he consulted with Professor Jaeyoon Song (Obstetrics & Gynecology, Korea University Anam Hospital) to develop Cerviray. While previous visual diagnoses had accuracies of 50-60%, image processing raised this above 70%. Backed by government support and the surge of AI interest spurred by AlphaGo, the company’s growth accelerated. He commented, “Although IT is advancing rapidly, the medical field has changed very slowly. Early on, there was tension between medical device companies and radiologists concerned about being replaced, but this is a misunderstanding. AI will never replace doctors; it will only assist them.” AIDOT’s technology and global activities have earned them awards such as the Prime Minister’s Award (Medical Device Day), Governor’s Award from the Gangwon Regulation-Free Zone, selection among Korea’s Top 100 R&D Achievements, and 1st place in the ITC Go Global Awards for medical technology. In addition to Cerviray, AIDOT has received approval for GIGA dot AI (gastroscopy diagnostic software), and is preparing to launch it globally. The company is also running clinical trials for other products such as SONO dot AI (carotid ultrasound), NAO dot AI (cerebral aneurysm rupture prediction), COLON dot AI (colonoscopy), BIO dot AI (chronic alcoholic liver disease microbiome), and TROC dot AI (thyroid cancer recurrence prediction), and has started developing ECHO dot AI for middle-ear, oral, and laryngeal diseases. CEO Jung concluded, “AIDOT’s vision is ‘AI Solutions for Humans’—establishing a system of medicine for humanity and saving lives using AI. Cerviray leads the way, with URO dot AI soon to follow, and we will continue developing and supplying innovative devices in the future.” 

The Medical / December 29, 2023 / Reporter: Wangkeun Kim