Lunit INSIGHT MMG
A Korean AI mammography reader used in screening programmes in Sweden and Australia and cleared in the US and Europe.
Overview
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.
Approvals
| Region | Year | Indication |
|---|---|---|
| EU | 2019 | CE mark |
| US | 2021 | 510(k) clearance, mammography lesion detection |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- 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.
Latest papers
topQuery for this drug: (TITLE:"Lunit INSIGHT MMG" OR ABSTRACT:"Lunit INSIGHT MMG") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Lunit INSIGHT MMG, not a curated reading list.
Pages like this
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