Lunit announced on the 15th that it has received medical device approval from the Ministry of Food and Drug Safety for its three-dimensional (3D) digital breast tomosynthesis (DBT) artificial intelligence (AI) image analysis solution.
The “Lunit Insight DBT” product analyzes 3D images from digital breast tomosynthesis based on AI, assisting medical professionals in diagnosing breast cancer. It is the first domestic breast cancer diagnostic AI solution to receive premarket approval (510k) from the U.S. Food and Drug Administration (FDA) in November 2023, and is supplying its product to major imaging centers in the U.S., including SimonMed Imaging and Rezolut. Lunit plans to accelerate its domestic sales following this approval from the Ministry of Food and Drug Safety.
This product enables accurate diagnoses compared to traditional two-dimensional mammography and provides precise diagnostics for dense breasts, commonly found in women of Asian descent, including those from Korea.
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, the AUC (area under the curve) of the Lunit Insight DBT recorded 0.92, demonstrating its outstanding performance. The closer the AUC is to 1, the better the performance, and anything above 0.8 is considered a high-performance model. It maintained high performance in an environment with various variables such as race, ethnicity, age, and breast density, and also scored well in relatively difficult types of interpretations, such as calcifications.
The Ministry of Health and Welfare designated DBT examinations as a new benefit item through a notification in March. Accordingly, an increase in the volume of DBT exams and a surge in demand for AI-based diagnoses are expected.
Lunit plans to focus on expanding its distribution network and product sales so that women undergoing screenings for breast cancer and patients who have received a cancer diagnosis can benefit from high-quality medical care and treatment through Lunit Insight DBT.
Seo bum-seok, the CEO of Lunit, noted, “Breast cancer has the highest incidence rate among cancers in women worldwide, causing significant socioeconomic losses during cancer diagnoses. Therefore, there is a high demand for precise diagnostics to detect cancer early.” He added, “Through this approval, we will strive to provide an environment where women can detect cancer early and receive timely treatment.”