Lunit to Launch 3D Breast Cancer Screening AI Solution in Europe by End of March

Europe 'MDR CE' Requirements Compliance

Medical AI company Lunit announced on the 20th that its 3D breast tomosynthesis AI imaging analysis solution, 'Lunit Insight DBT,' has recently met the new European Union (EU) medical device regulation requirements known as 'MDR CE.' Accordingly, Lunit plans to start selling this solution in the European market from the end of this month.

Lunit Insight DBT.
Photo by Lunit

The European MDR (Medical Device Regulation) CE certification is a regulation that strengthens the performance and quality review standards for medical devices compared to the previous MDD (Medical Device Directive) CE certification. Since the EU will ban the sale of products without MDR CE certification starting May 2024, obtaining this certification is essential for entering the European market.

Previously, Lunit had also obtained MDR CE certification for products such as the chest X-ray AI imaging analysis solution 'Lunit Insight CXR' and the mammography AI imaging analysis solution 'Lunit Insight MMG' at the end of last year.

Lunit Insight DBT is a product that analyzes 3D images from breast tomosynthesis (DBT) to assist medical professionals in diagnosing breast cancer. According to Lunit, 3D DBT allows for more precise examinations compared to traditional 2D mammography, leading to high demand in advanced medical institutions in countries such as the United States and Europe.

Seobum Seok, CEO of Lunit, stated, "Since Lunit Insight DBT meets the strengthened European MDR CE regulations, we will expand sales not only in the European market but also in other global markets such as the United States and Australia, which adopt European regulations."

Meanwhile, Lunit plans to proceed with the approval process for Insight DBT within this year in the United States, the world's largest medical market.