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Lunit INSIGHT MMG, an AI Solution for Breast Cancer Detection, Now CE Approved

  • Developed by Lunit, the company specializing in medical AI, the software detects breast cancer with an accuracy of 97%
  • A study published in Lancet Digital Health shows that the radiologists helped by Lunit INSIGHT MMG obtain better results

Lunit announced that its AI solution for breast cancer, Lunit INSIGHT MMG, has received CE certification. Medical software received approval on May 26, which now makes it available in the European Economic Area.

Licensed software, Lunit INSIGHT MMG, released to the public at the Radiological Society of North America (RSNA) annual meeting in 2018, analyzes mammography images with 97% accuracy, which helps locate suspicious lesions of breast cancer and obtain an abnormality score reflecting the probability of the existence of lesions.

“Of the patients who are suspected of having breast cancer during a screening mammogram, only 29% are found to have it after a biopsy,” said Brandon Suh , CEO of Lunit. “I am delighted to present Lunit INSIGHT MMG, now CE approved, to healthcare professionals and institutions on the European continent. Through our AI software, we want to increase the efficiency of mammography screening and reduce unnecessary biopsies. “

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Last February, a study on the use of Lunit INSIGHT MMG was published in Lancet Digital Health , showing the added value of breast cancer detection assisted by AI from mammography images. The study included a dataset of over 36,000 independent, biopsy-confirmed cancer cases, the largest scale of cancer data among AI studies related to mammography.

The study showed a significant improvement in the performance of radiologists after using AI. According to the study, AI alone showed a sensitivity of 88.8% in the detection of breast cancer, while for radiologists the percentage is 75.3%. When radiologists were helped by AI, the accuracy increased by 9.5%, or 84.8%.

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“AI provides double-reading help, which is recommended by European directives,” said Minhong Jang , Lunit’s sales manager. “Applied to the screening framework in Europe , Lunit INSIGHT MMG should make it possible to relieve the pressure thanks to double reading, while increasing the precision of the interpretation of mammography images. “

At the end of last year, Lunit had received CE marking for its AI solution applied to chest radiography, Lunit INSIGHT CXR. According to the company, the software has analyzed more than a million chest x-ray images on a commercial scale since its approval. It is currently used or clinically tested in Portugal , Italy, France , Mexico, the United Arab Emirates, Thailand, South Korea and other countries.

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