Lunit Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3D Breast Tomosynthesis (DBT) AI solution, Lunit INSIGHT DBT. This approval signifies a major step forward in the fight against breast cancer, enabling Lunit to make a full-fledged entry into the US breast screening market. Lunit INSIGHT DBT is an AI algorithm engineered to analyze 3D images generated by DBT equipment.

DBT imaging offers a faster and more accurate breast cancer diagnosis compared to traditional 2D mammography screenings. With DBT's capability to provide more precise breast cancer examinations, the demand for this technology is high, especially among advanced medical institutions in the US, which accounts for over 64% of the global demand for DBT. As of November 2023, 88% of the total 8,850 facilities in the US certified by the Mammography Quality Standards Act and Program (MQSA) are certified units with DBT.