SEOUL, South Korea, June 2, 2020 /PRNewswire/ -- Lunit today announced that its AI solution for breast cancer, Lunit INSIGHT MMG, has been CE certified. The medical software was certified on May 26th, making it now commercially available across the European Economic Area.
The certified software, Lunit INSIGHT MMG, publicly introduced during the 2018 Radiological Society of North America (RSNA) annual meeting, analyzes mammography images with 97% accuracy, providing the location of lesions suspicious for breast cancer, and an abnormality score that reflects the probability of the existence of detected lesions.
"Among the patients suspicious of breast cancer upon screening mammography, only 29% is actually diagnosed with cancer after a biopsy," said Brandon Suh, CEO of Lunit. "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."
Recently in February, a study using Lunit INSIGHT MMG was published in Lancet Digital Health, showing the added value of AI-aided breast cancer detection from mammography images. The study included a dataset of over 36,000 biopsy-proven, independent cancer positive cases—the largest scale of cancer data among mammography-related AI studies.
The study showed a significant improvement in the performance of radiologists, before and after using AI. According to the study, the AI alone showed 88.8% sensitivity in breast cancer detection, whereas radiologists alone showed 75.3%. When radiologists were aided by AI, the accuracy increased by 9.5% to 84.8%.
"AI can provide assistance in double-reading, which is recommended by the European guidelines," said Minhong Jang, Chief Business Officer at Lunit. "When applied to the screening environment in Europe, Lunit INSIGHT MMG is expected to relieve the pressure of double-reading while increasing interpretation accuracy of mammography images."
In late last year, Lunit had received a CE mark for its AI solution for chest x-ray, Lunit INSIGHT CXR. According to the company, the software had commercially analyzed more than 1,000,000 chest x-ray images since the regulatory clearances. It is currently being clinically used or tested in Portugal, Italy, France, Mexico, UAE, Thailand, South Korea, and more.
Media contact:
Jussarang Lee
media@lunit.io
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