Lunit announced today that it received CE Mark approval in Europe for its Lunit Insight MMG artificial intelligence-based software.
Insight MMG uses AI to analyze mammography images and provide the location of lesions that are suspicious for breast cancer, along with an abnormality score that reflects the probability of the existence of detected lesions. According to a news release, the software analyzes the images with 97% accuracy.
Lunit touted a recently published study in which AI alone showed 88.8% sensitivity in breast cancer detection, while radiologists alone showed 75.3%. When radiologists were aided by AI, their accuracy increased to 84.8%. This data came from a set of over 36,000 biopsy-proven, independent cancer-positive cases.
“Among the patients suspicious of breast cancer upon screening mammography, only 29% is actually diagnosed with cancer after a biopsy,” Lunit CEO Brandon Suh said in the release. “I am delighted to introduce Lunit Insight MMG, now CE certified, to healthcare professionals and institutions across the continent of Europe.
“With our AI software, we would like to increase the effectiveness of mammography screening and reduce unnecessary biopsies.”
Last November, Seoul-based Lunit received CE Mark approval for its Insight CXR up-to-date chest X-ray analysis AI that is capable of detecting 10 major chest abnormalities, including nodule, calcification, pneumothorax, consolidation, fibrosis and more, while also supporting tuberculosis screening.