Lunit Meets MDR CE Requirements for 3D Breast Tomosynthesis AI Solution

• Lunit set to launch Lunit INSIGHT DBT in the European market
• Lunit seeks FDA clearance, paving the way into the US market

SEOUL, South Korea, March 20, 2023 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer solutions, today announced that its AI solution for 3D Breast Tomosynthesis (DBT) analysis, Lunit INSIGHT DBT, has met the requirements of the CE marking under Europe's latest Medical Device Regulation (MDR).

The MDR CE certification is a more stringent requirement for medical devices than the existing Medical Device Directive (MDD), ensuring higher performance and quality standards. From May 2024, products without MDR CE certification will be banned from sale in the EU, making it vital for companies to obtain this certification to enter the market. In 2022, Lunit secured CE marking under EU MDR for Lunit INSIGHT CXR, an AI solution for chest x-ray analysis, and Lunit INSIGHT MMG, an AI solution for mammography analysis, becoming the first software as a medical device (SaMD) company in the Asia Pacific region to earn it.

Lunit developed Lunit INSIGHT DBT based on the evaluation that Lunit INSIGHT MMG is one of the most precise AI for commercialized breast screening. Lunit INSIGHT DBT analyzes 3D images from DBT to enable fast and accurate diagnosis of breast cancer. With DBT's ability to provide more precise examinations than traditional 2D breast imaging, the demand is on the rise in advanced medical institutions, particularly in the US and Europe. To meet this demand, Lunit plans to commence the launch of Lunit INSIGHT DBT in the European market with a planned start date around the end of March.

"Last year in June, Lunit successfully developed Lunit INSIGHT DBT, our revolutionary 3D breast cancer screening AI solution. Following clearance from the Korean Ministry of Food and Drug Safety earlier this year, we have been working tirelessly to obtain regulatory approvals in other countries," said Brandon Suh, CEO of Lunit. "We are thrilled to introduce our groundbreaking product to the European market, confident that it will significantly contribute to improving accuracy of breast cancer diagnosis and ultimately, saving more lives."

Within the third quarter of this year, Lunit intends to start the process of obtaining FDA approval for Lunit INSIGHT DBT as a means to enter the US market.

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