{"entity":{"id":"lunit-insight-mmg","kind":"drug","name":"Lunit INSIGHT MMG","aka":[],"tldr":"A Korean AI mammography reader used in screening programmes in Sweden and Australia and cleared in the US and Europe.","summary":"Lunit INSIGHT MMG is CE-marked and received FDA 510(k) clearance in 2021. It has been evaluated as a stand-alone and second reader in Swedish population screening (the Capital Region of Denmark and Sweden's Capio S:t Göran reported detection and workload outcomes) and in the Australian BreastScreen system, and Lunit acquired Volpara in 2024 to add breast density and risk assessment. Prospective randomised evidence for Lunit's software is less mature than for Transpara, but the two products are the most widely deployed AI readers in European screening.","status":"approved","asOf":"2026-09-24","links":[{"label":"ScreenTrustCAD (Lancet Digital Health 2023)","url":"https://doi.org/10.1016/S2589-7500(23)00153-X"},{"label":"Lunit INSIGHT MMG","url":"https://www.lunit.io/en/products/mmg"}],"tags":["test"],"related":[],"cancers":["breast-hr-positive","tnbc"],"sections":[],"technologies":["radiology-ai-screening","mammography"],"targets":[],"drugs":[],"companies":["lunit"],"institutions":[],"pathways":[],"terms":[],"trials":["screentrustcad"],"people":[],"bottlenecks":[],"keyPapers":["paper-screentrustcad-dembrower-lancet-digit-health-2023"],"journals":[],"dependsOn":[],"notes":["What a result means: as with other AI readers, the software flags areas for a radiologist; it can also estimate breast density, which affects how well mammograms work for you."],"brand":"Lunit INSIGHT MMG","modality":"AI mammography detection software","mechanism":"Convolutional neural network trained on large mammography datasets marks suspicious lesions and gives an abnormality score per breast.","approvals":[{"region":"EU","year":2019,"indication":"CE mark"},{"region":"US","year":2021,"indication":"510(k) clearance, mammography lesion detection"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/lunit-insight-mmg/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"radiology-ai-screening","kind":"technology","name":"AI in radiology","route":"/technologies/radiology-ai-screening/"},{"id":"mammography","kind":"technology","name":"Mammography & tomosynthesis","route":"/technologies/mammography/"}],"company":[{"id":"lunit","kind":"company","name":"Lunit","route":"/companies/lunit/"}],"trial":[{"id":"screentrustcad","kind":"trial","name":"ScreenTrustCAD","route":"/trials/screentrustcad/"}],"paper":[{"id":"paper-screentrustcad-dembrower-lancet-digit-health-2023","kind":"paper","name":"Artificial intelligence for breast cancer detection in screening mammography in Sweden: a prospective, population-based, paired-reader, non-inferiority study (ScreenTrustCAD)","route":"/key-papers/paper-screentrustcad-dembrower-lancet-digit-health-2023/"}]}}