SEOUL, South Korea, Nov. 18, 2021 / PRNewswire / – Lunit, a leading provider of medical AI, today announced that the U.S. Food and Drug Administration (FDA) 510 (k) has cleared its solution Institute for Breast Cancer Detection, ‘Lunit INSIGHT MMG’. With its “Lunit INSIGHT CXR Triage” chest x-ray triage solution, the company’s AI solution for chest x-ray and mammography is now commercially available in the United States.
“I am delighted to report the good news and introduce Lunit INSIGHT MMG to healthcare professionals and institutions across the United States,” said Brandon Suh, CEO of Lunit. “With our AI solution, we hope to increase the efficiency and accuracy of mammography screening as well as chest x-ray triage. We can help radiologists diagnose disease at an earlier stage, helping patients get treated at the right time. “
Lunit INSIGHT MMG is one of the company’s most mature radiology products that analyzes mammography images with high precision. It provides the location of suspicious breast cancer lesions and an abnormality score that reflects the confidence of the AI in the existence of detected lesions.
The product is formed with large-scale data from over 240,000 mammogram cases which include up to 50,000 breast cancer cases, and is known to show excellent performance in detecting breast cancer at a stage earlier.
According to a study published in JAMA Oncology in 2020, Lunit INSIGHT MMG showed the best accuracy among three marketed AIs to identify breast cancer. It turned out to have about 15% higher sensitivity compared to the other two algorithms. The FDA-approved AI solution has already been CE marked and approved for commercial sales in over 35 countries around the world.
“This is an important milestone and a business opportunity for us as the United States is one of the largest and most important markets covering over 45% of the global imaging market. breast, ”added Suh. “Based on FDA clearance, we will not only bring diagnostic value to healthcare professionals and patients in the United States, but we will also leverage our business to become one of the world’s leading suppliers of breast AI solutions. “
Lunit INSIGHT MMG will be showcased at RSNA 2021, which will be held from November 28 to December 2, 2021 in Chicago. The Lunit booth will be located in AI Showcase, booth # 4545.
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