CureMetrix vs Digital Diagnostics

CureMetrix's cmAngio, most recently cleared as V2.0 (K260980) in July 2026, quantifies breast arterial calcification on screening mammograms. The homepage claims an AUC of 0.98 to 0.992 and more than 400 US sites, both the vendor's own figures. A breast imaging site that wants a cardiovascular finding out of studies it already reads buys it.

Digital Diagnostics sells LumineticsCore, which the FDA record still files as IDx-DR. That record lists De Novo DEN180001 (April 2018), K203629 (June 2021) and K213037 for v2.3 (June 2022). The vendor says it makes the diagnosis without physician input, that it is indicated for adults 22 and older with diabetes and for use with the Topcon NW400, and that a result returns within 30 seconds of image submission. A primary care group or community health center screening diabetic patients buys it. A breast imaging site and a primary care clinic run separate screening programs, so the two products have different buyers. CPT 92229 covers the exam, and Cahaba Medical Care and Zufall Health are named customers.