CureMetrix vs Infervision

Lung nodules on CT and arterial calcification on mammograms are separate screening jobs. A lung screening program reads Infervision's output, a mammography group reads CureMetrix's, and the two vendors meet only in an imaging center that offers both.

CureMetrix's cmAngio detects and quantifies breast arterial calcification on screening mammograms (K232367, decided October 5, 2023, and K260980, decided July 30, 2026). Vendor data puts AUC at 0.98 to 0.992. The products page says its mammography CAD, cmAssist, is cleared only in Brazil and still under development in the US.

Infervision's InferRead Lung CT.AI is computer-aided detection for pulmonary nodules (K192880, decided July 2, 2020, and K240554, decided May 16, 2025). Its product page lists follow-up registration with volume doubling time, while quantification of nodule growth, emphysema and coronary calcium is marked "For investigational use only." The vendor claims 99% sensitivity with AI-assisted reading and a 33% cut in reading time, the second figure from a Wake Radiology talk.