Lunit vs ScreenPoint Transpara

Lunit's mammography records run through April 2026 and Transpara's through August 2026, with eight Transpara 510(k) records against five Lunit records for breast imaging. Transpara supports cancer detection on 2D and 3D mammograms and added a density tool (K232096). The vendor says the MASAI randomized trial in Swedish screening used it, and cites 12% fewer interval cancers and sensitivity of 80.5% against 73.8% at 98.5% specificity, from a Lancet paper by Lund University. Lunit offers breast and chest products from one vendor, with its chest X-ray record limited to triage (K211733) and Volpara tools for density and positioning. Its 2026 European Radiology paper follows long-term prognosis of AI-detected versus undetected cancers on INSIGHT MMG v1.1.8.2. A screening service that wants a randomized trial behind its reading support has one for Transpara, per the vendor, and a prognosis study for Lunit. A center that wants chest X-ray triage (K211733) alongside breast work goes to Lunit.