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A Korean AI mammography reader used in screening programmes in Sweden and Australia and cleared in the US and Europe.
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.
Convolutional neural network trained on large mammography datasets marks suspicious lesions and gives an abnormality score per breast.
1.Lunit INSIGHT MMG slips into a pocket on its target.
| Region | Year | Indication |
|---|---|---|
| EU | 2019 | CE mark |
| US | 2021 | 510(k) clearance, mammography lesion detection |
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Shares Mammography & tomosynthesis, AI in radiology, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares Mammography & tomosynthesis, AI in radiology, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares AI in radiology and the tag test.
Shares Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.