Seoul, South Korea-based AI developer Lunit has received U.S. Food and Drug Administration (FDA) clearance for its 3D digital breast tomosynthesis (DBT) AI software, Insight DBT.
The clearance allows Lunit to enter the U.S. breast screening market, the company said.
Lunit Insight DBT is an AI algorithm designed 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, the company added.
