Lunit vs Qure.ai

Qure.ai holds ten FDA 510(k) records to Lunit's six, and the chest X-ray entries differ. Lunit's chest X-ray record is INSIGHT CXR Triage, cleared in 2021. Qure's qXR-LN (K231805) was cleared in December 2023 for radiologists, pulmonologists and ER physicians reading adult frontal chest radiographs, and qXR-PTX-PE adds pneumothorax and effusion triage. Qure also reads head CT with qER. Lunit's other records cover 2D mammography and tomosynthesis, with Volpara tools for density, so a breast imaging center that also reads chest films buys from Lunit. A US hospital shopping for nodule detection on radiographs finds Lunit gives way to Qure. On TB, an independent PLOS Digital Health comparison found a newer INSIGHT CXR version less accurate until its threshold was recalibrated, while an independent 12-product evaluation put qXR v3 at 95.5% sensitivity with 48.7% specificity at one threshold.