Lunit INSIGHT MMG Increases Accuracy of Mammography Screening
Lunit, a medical artificial intelligence (AI) solution developer, announced on Nov. 18 that the U.S. Food and Drug Administration (FDA) has cleared its AI-powered breast cancer diagnosis solution "Lunit INSIGHT MMG."
Lunit INSIGHT MMG is one of the company's most mature radiology products which analyzes mammography images with high accuracy. It provides the location of lesions suspicious of breast cancer and an abnormality score that reflects the AI's confidence of the existence of detected lesions.
Lunit obtained approval for the solution from the Korean Ministry of Food and Drug Safety in July 2019 and received European CE certification in June 2020. The FDA’s clearance will allow Lunit to sell Lunit Insight MMG in the United States.
Earlier, Lunit also received approval for Lunit Insight CXR Triage, an AI-powered chest x-ray triaging solution, from the FDA. Based on these FDA approvals, the company is planning to actively sell Lunit Insight products to the global market.