Cleerly vs Qure.ai

Qure.ai holds ten FDA 510(k) records, every one for a chest X-ray, head CT or lung CT product. qXR-LN is cleared for lung nodule detection by radiologists, pulmonologists and ER physicians reading adult frontal chest radiographs, and qER triages head CT. For tuberculosis screening, no FDA record carries that name, and the use rests on a 2021 WHO endorsement and CE marking. An independent evaluation of twelve TB products put qXR v3 at 95.5% sensitivity with 48.7% specificity at one threshold, and the CREATE study reported a 54.2% positive predictive value and 93.5% negative predictive value for its nodule malignancy score.

Qure.ai's cleared products suit a hospital radiology department reading chest films and head CT, and its WHO-endorsed TB tool suits a screening program. Cleerly suits an imaging group reading coronary CTA, with UnitedHealthcare, Cigna and Humana on its coverage list and CPT 75577 in effect. A department with both chest films and coronary CTA would contract both, since the tools cover different exams.