Lunit Obtains MFDS Export Approval for Breast Cancer Screening AI Solution

Lunit Insight DBT
Using AI for 3D Medical Image Interpretation
Aiming for Commercialization of 'Global Big Market' Product

3D breast tomosynthesis AI image analysis solution 'Lunit Insight DBT'.
/Photo by Lunit

[Asia Economy Reporter Myunghwan Lee] Medical artificial intelligence (AI) company Lunit announced on the 19th that it has received export approval from the Ministry of Food and Drug Safety for its three-dimensional (3D) breast tomosynthesis AI image analysis solution, 'Lunit Insight DBT.'

The new breast tomosynthesis (DBT) product, Lunit Insight DBT, interprets 3D DBT images through AI to assist medical professionals in diagnosis. While conventional two-dimensional mammography is the primary test for breast cancer diagnosis, DBT allows for detailed examination of detected nodules, increasing its utilization in medical institutions, according to Lunit.

In particular, Lunit emphasized that for dense breasts, which are common among East Asian women including Koreans, breast cancer identification is often difficult through conventional mammography or ultrasound, making this product optimized for precise diagnosis.

Lunit plans to accelerate the supply of Lunit Insight DBT to major markets such as the United States and Europe, where breast cancer is the leading cancer among women worldwide and there is high demand for precise breast cancer diagnosis.

Seobeom Seok, CEO of Lunit, stated, "With this export approval from the Ministry of Food and Drug Safety, immediate sales of Lunit Insight DBT to global countries have become possible. We will focus all our capabilities on meeting the requirements for approval from the U.S. Food and Drug Administration (FDA) and the European CE mark in the second half of this year to enable product launch in those regions."

The global breast cancer diagnostic device market was estimated at approximately 2 trillion KRW as of 2020. Among this, the 3D breast cancer diagnostic device market accounts for more than 20% of the total market and is expected to show a compound annual growth rate (CAGR) of 18.5%.

This content was produced with the assistance of AI translation services.