'Lunit Insight DBT' Receives FDA 510k Clearance

Medical AI company Lunit announced on the 14th that its 3D breast tomosynthesis AI image analysis solution, 'Lunit Insight DBT,' has received premarket approval (510(k) Clearance) from the U.S. Food and Drug Administration (FDA). The 510(k) is a system through which the FDA verifies the safety and efficacy of medical devices. This is the first time a domestically developed 3D breast cancer detection AI solution has obtained FDA approval.

Lunit's 3D Breast Tomosynthesis AI Image Analysis Solution 'Lunit Insight DBT'
[Photo by Lunit]

Lunit Insight DBT is a product that analyzes 3D images from digital breast tomosynthesis (DBT) using AI to assist medical professionals in diagnosing breast cancer. Compared to conventional 2D mammography, it offers faster and more accurate diagnoses, leading to high demand in advanced countries such as the United States.

Lunit plans to use this FDA certification as a stepping stone to fully enter the U.S., the world's largest healthcare market. The U.S. accounts for 65% of the global breast cancer screening market, with over 40 million women undergoing screening annually. Notably, about 90% of breast cancer screening institutions in the U.S. have adopted DBT equipment, making breast cancer screening via DBT widespread. In addition, Lunit established its subsidiary, Lunit Europe Holdings, in February and launched Lunit Insight DBT in Europe.

Seobum Seok, CEO of Lunit, said, "In advanced medical markets like the U.S., 3D breast tomosynthesis has already become the mainstream, surpassing 2D mammography screening. Considering the high demand for precise breast cancer diagnosis in U.S. medical institutions, we will strengthen sales and marketing activities targeting local healthcare providers with our highly accurate AI solution and rapidly expand the market."

With the approval of Lunit Insight DBT, Lunit has succeeded in increasing the number of FDA-approved products to three, following the AI emergency disease automatic classification solution 'Lunit Insight CXR Triage' and the mammography AI image analysis solution 'Lunit Insight MMG.'