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BioWorld - Sunday, March 15, 2026
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Home » Lunit secures South Korean innovative medical device designation for AI breast cancer detection software
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Lunit secures South Korean innovative medical device designation for AI breast cancer detection software

Sep. 14, 2021
By Gina Lee
Lunit Inc. won an innovative medical device designation from South Korea’s Ministry of Food and Drug Safety (MFDS). The designation was for Lunit Insight MMG, its commercial artificial intelligence (AI) solution for breast cancer detection from mammography images. The company said that Lunit Insight MMG is now the first medical device of its type to receive the designation, and the company now has its second innovative medical device designation. “All of our commercialized products are now designated innovative medical devices by the MFDS. We will ensure that our Lunit Insight AI products allow medical staff to rapidly and accurately diagnose patients,” said Beomseok Suh, CEO at Lunit.
Medical technology Regulatory Artificial intelligence Digital health Cancer Asia-Pacific

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