Lunit Receives Korea MFDS Approval for its AI Solution for Breast Cancer, Lunit INSIGHT MMG

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Lunit has announced Korea MFDS (Ministry of Food and Drug Safety) approval of its AI solution for breast cancer, Lunit INSIGHT MMG. The medical software has been approved on July 29th, which marks a second approval of its AI solution by Korea MFDS since last year, when Lunit had gained initial regulatory clearance of its AI software.

Lunit INSIGHT MMG, which is now available for domestic sales in Korea, runs on Lunit’s proprietary AI technology, co-developed with prestigious Korean medical institutions--Yonsei Severance Hospital, Asan Medical Center, and Samsung Medical Center. 

The software analyzes mammography images, with an indication of the location of lesions suspicious for breast cancer and an abnormality score of the detected lesion. 

“Mammography is not easy to diagnose,” said Brandon Suh, CEO of Lunit. “Breast cancer is one of the most common female cancer, taking up to 24% of all female cancer cases. Among the patients suspicious of breast cancer after screening mammography, only 29% is actually diagnosed with cancer after biopsy.”

“With AI, we would like to increase the effectiveness of mammography screening and reduce unnecessary biopsies,” added Suh. “Lunit INSIGHT will improve the diagnosis accuracy of radiologists and decrease unnecessary recalls.”

According to the company, the algorithm is designed to assist prompt and accurate diagnosis of physicians, by showing only malignant lesion and automatically ignoring benign lesion. It has been trained with over 200,000 mammography cases, which includes 50,000 breast cancer cases.

“High false positive rate has been a major problem of CAD (Computer Aided Detection) software,” said Hyo-Eun Kim, Head of Breast Radiology at Lunit. “To overcome this problem, our software has been developed to distinguish benign and malignant lesion with high accuracy. The MFDS clinical trials had shown that Lunit INSIGHT MMG can significantly improve the diagnostic accuracy of radiologists.”

Lunit provides an online demo ( for users to test the performance of its software. “Anyone can try using our algorithm through this website,” said Minhong Jang, CBO of Lunit. “With Lunit INSIGHT MMG, breast cancer can be diagnosed earlier. It will also reduce the burden of patients due to unnecessary additional tests.”

The company had previously received MFDS clearance last year in August for its AI solution for chest x-ray. The software is currently being used at multiple hospitals and medical examination centers throughout the country, including Seoul National University Hospital.

About Lunit

Perfecting Intelligence, Transforming Medicine.

With AI, we aim to make data-driven medicine the new standard of care. We are especially focused on conquering cancer, one of the leading causes of death worldwide.

We develop AI solutions for precision diagnostics and therapeutics, to find the right diagnosis at the right cost, and the right treatment for the right patients.

Lunit, abbreviated from “learning unit,” is an AI software company devoted to developing advanced medical image analytics and data-driven imaging biomarkers via cutting-edge deep learning technology.

Founded in 2013, Lunit has been internationally acknowledged for its advanced, state-of-the-art technology and its application in medical images. Lunit has been named by CB Insights as one of “AI 100” startups transforming healthcare industry.

Lunit's technology has been recognized at international competitions such as ImageNet (5th place, 2015), TUPAC 2016 (1st place), and Camelyon 2017 (1st place), surpassing top companies like Google, IBM, and Microsoft. Lunit is based in Seoul, South Korea.

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