Lunit receives approval for 3D breast tomosynthesis AI solution

Lunit, a Korean medical AI imaging company, said it obtained approval from the Ministry of Food and Drug Safety (MFDS) for its 3D breast tomosynthesis AI analysis solution, Lunit INSIGHT DBT (digital breast tomosynthesis).

The software supports physicians in breast cancer diagnosis by analyzing 3D images acquired through breast tomosynthesis scans.

This is the first Korean-developed AI solution for 3D mammography to receive clinical use approval. Lunit INSIGHT DBT previously received premarket approval from the U.S. FDA in November 2023 and has since been adopted by leading U.S. imaging centers, including SimonMed Imaging and Rezolut.

The clinical efficacy of Lunit INSIGHT DBT has also been validated in international studies. At the Radiological Society of North America (RSNA) 2024 annual meeting, researchers from Emory University Hospital presented data showing the solution achieved an area under the curve (AUC) score of 0.92. The study confirmed that the AI maintained strong performance across diverse populations, including various racial and ethnic groups, age ranges, and breast densities.

With the latest regulatory milestone, Lunit plans to accelerate the product’s launch and expand its distribution within Korea.

Unlike conventional 2D mammography, Lunit INSIGHT DBT enables higher diagnostic accuracy, especially for women with dense breast tissue—a characteristic common among Korean and other East Asian women.

The AI solution offers improved detection of subtle lesions, including microcalcifications, which are often difficult to interpret.

Demand for such solutions is expected to rise following the Korean Ministry of Health and Welfare’s decision in March to include DBT as a reimbursable screening procedure under the national insurance scheme. The policy change is anticipated to significantly boost the volume of DBT exams and create greater demand for AI-assisted diagnostic tools.

Lunit emphasized that Lunit INSIGHT DBT will help enhance the quality of care for both women undergoing breast cancer screenings and those already diagnosed, by facilitating early and accurate detection.

“Breast cancer is the most commonly diagnosed cancer among women worldwide, and it carries a significant socioeconomic burden when diagnosed late,” Lunit CEO Brandon Suh said. “This approval brings us one step closer to providing women with timely access to precision diagnostics and life-saving treatment.”