Medical artificial intelligence (AI) provider Lunit announces that the U.S. FDA has granted 510(k) clearance to its Lunit Insight MMG technology for breast cancer detection. Along with its chest x-ray triaging solution Lunit Insight CXR Triage, the company’s AI technology for both chest x-ray and mammography is now commercially available across the U.S.
“I am delighted to deliver the great news and to introduce Lunit Insight MMG to healthcare professionals and institutions across the U.S.,” says 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 triaging. We can assist radiologists diagnose diseases at an earlier stage, helping patients be treated at the right time.”
Lunit Insight MMG—trained with a large-scale data of more than 240,000 mammography cases that include up to 50,000 breast cancer cases—is known to show strong performance in finding breast cancer at an earlier stage. Moreover, the FDA-cleared AI solution has been previously CE-marked and approved for commercial sales in more than 35 countries worldwide.
“This is a huge milestone and business opportunity for us, as the U.S. is one of the largest and most important markets that covers more than 45% of the global breast imaging market,” adds Suh. “Based on the FDA clearance, we will not only bring diagnostic value to medical professionals and patients in the U.S. but leverage our business to be a leading global provider of breast AI solution.”