Lunit Obtains MFDS Approval for 3D AI Breast Cancer Analysis Solution

Medical artificial intelligence (AI) company Lunit announced on May 15 that it has recently obtained medical device approval from the Ministry of Food and Drug Safety (MFDS) for its three-dimensional (3D) breast tomosynthesis AI image analysis solution, 'Lunit INSIGHT DBT'.

Lunit INSIGHT DBT is a product that assists medical professionals in diagnosing breast cancer by analyzing 3D images from breast tomosynthesis using AI. This product is the first domestic AI solution for breast cancer diagnosis to receive pre-market approval from the U.S. Food and Drug Administration (FDA) in November 2023, and it is currently being supplied to major imaging centers in the United States, including SimonMed Imaging and Rezolut.

With this MFDS approval, Lunit plans to accelerate domestic sales. Lunit INSIGHT DBT enables more accurate diagnoses compared to conventional two-dimensional mammography and provides precise diagnostics for dense breasts, which are commonly found in East Asian women, including those in Korea. Demand is particularly high for this reason. In March, the Ministry of Health and Welfare newly designated DBT examinations as a reimbursable item through an official notice. As a result, both the volume of DBT examinations and the demand for AI-based diagnostics are expected to increase rapidly.

Lunit intends to focus on expanding its distribution network and product sales so that women undergoing breast cancer screening and patients diagnosed with cancer can benefit from high-quality care and treatment outcomes through Lunit INSIGHT DBT. Lunit CEO Seo Beomseok stated, "Breast cancer has the highest incidence among female cancers worldwide and causes significant socioeconomic losses when diagnosed. Therefore, there is strong demand for precise diagnostics to detect cancer early. Through this approval, we will strive to create an environment where women can detect cancer in advance and receive timely treatment by supplying our product."

Meanwhile, according to a study presented by a research team from Emory University Hospital at the Radiological Society of North America (RSNA) held at the end of last year, Lunit INSIGHT DBT demonstrated excellent performance with an AUC (AI model performance metric) of 0.92. Notably, it maintained high performance even in environments with diverse variables such as race, ethnicity, age, and breast density, and it showed high diagnostic accuracy even for lesion types that are relatively difficult to interpret, such as calcifications.