After introduction in 20 Korean hospitals and obtaining U.S. FDA 510(k) clearance, the company expands into the Japanese market, participating in ITEM in Japan.
Oncosoft, a medical AI company specializing in radiation therapy, announced on the 16th that it has obtained Japanese medical device certification for its AI-based auto-contouring solution, ‘OncoStudio.’
After receiving approval from the Korean Ministry of Food and Drug Safety in 2022, OncoStudio has proven its clinical effectiveness and safety in over 20 hospitals in Korea. In February, it received 510(k) clearance from the U.S. Food and Drug Administration (FDA), officially recognizing its global technological prowess, and has now added Japanese certification.
The solution uses AI to automatically recognize and outline human organs and tissues, supporting rapid and precise radiation therapy planning. To date, it has analyzed over 8 million organs based on data from approximately 160,000 patients, and a demo version is in use at five medical institutions in Japan, including the National Institutes for Quantum and Radiological Science and Technology (QST) and Yamagata University Hospital.
The company is developing a multi-modal auto-contouring technology that analyzes imaging data and clinical findings together, based on the technological potential of AI and Large Language Models (LLM). Through this, the company plans to enhance the accuracy of tumor target setting and more effectively support the diagnoses of medical professionals.
Additionally, the company operated a joint booth with its partner, Anzai Medical, at the 2025 International Technical Exhibition of Medical Imaging (ITEM) held in Yokohama on the 11th, where it directly showcased the product's competitiveness to local medical staff and industry officials. During the same period, Oncosoft CEO Kim Jinsung, who is also a professor in the Department of Radiation Oncology at Yonsei University, was invited as a speaker at the Japan Radiology Congress (JRC). He gave a presentation on "The fusion of AI and LLM: Shaping the future in Radiation Oncology."
CEO Kim explained, "The fusion of AI and LLM is a future technology that can enhance the precision and efficiency of radiation therapy," and "AI and LLM will become key tools to realize the precise art of radiation therapy to a high degree of perfection."
An Oncosoft official stated, "Through this Japanese medical device certification and participation in ITEM 2025, OncoStudio's technology has been officially recognized in the Japanese market." The official added, "Based on our collaboration with Anzai Medical, we will not only expand our supply within Japan but also continue to pursue medical device certifications and market expansion in key global markets such as Europe, Southeast Asia, and the Middle East."
