The Food and Drug Administration (FDA) has granted 510(k) clearance for Lunit’s artificial intelligence (AI) software, Lunit INSIGHT MMG, for breast cancer detection.

Lunit INSIGHT MMG is a deep learning based software that assists radiologists in analyzing mammograms. The AI solution is intended to detect the location of lesions suspicious of breast cancer.

According to the Company, Lunit INSIGHT MMG is trained with large-scale data of more than 240,000 mammography cases that include up to 50,000 breast cancer cases. An abnormality score is also provided to reflect the AI’s confidence for the existence of detected lesions.

The clearance is supported by a study published in JAMA Oncology in 2020, which demonstrated the superiority of Lunit INSIGHT MMG at detecting breast cancer compared with 2 other commercialized AIs. Lunit INSIGHT MMG was found to have 15% higher sensitivity compared with the other algorithms.


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Lunit INSIGHT MMG and its chest X-ray triaging solution, Lunit INSIGHT CXR Triage, are both now commercially available.

Reference

Lunit’s AI Software for breast cancer detection, Lunit INSIGHT MMG, wins FDA clearance. News release. Lunit. November 18, 2021. Accessed November 19, 2021. https://www.lunit.io/en/news/lunits-ai-software-for-breast-cancer-detection-lunit-insight-mmg-wins-fda-clearance. 

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