Circle Cardiovascular Imaging vs DeepHealth

DeepHealth is a RadNet subsidiary that has grown by acquisition. iCAD closed in July 2025, and Gleamer was announced in March 2026. Its products cover mammography, breast density, breast arterial calcification (K254131, May 21, 2026), prostate, lung, bone and chest X-ray. Circle's cvi42 modules are Cardiac MR, Cardiac CT, Vascular CT, Interventional Planning, Electrophysiology and AI Plaque Analysis, with StrokeSENS for acute stroke.

For an outpatient imaging chain whose volume is screening mammography, Circle loses. Its twelve openFDA records run from K082628 to K251027 and cover cardiac MR and CT, TruPlan, strain, plaque and stroke software, while DeepHealth's record carries Saige-Dx (K253825, June 15, 2026) for mammography detection. A vendor-affiliated Saige-Dx reader study in Radiology: AI, with 18 readers and 240 cases, reported AUC gains of 0.08 for general radiologists and 0.05 for specialists. Its authors are DeepHealth employees and the case set was retrospective and enriched.

A hospital cardiology department standing up cardiac MR and CT analysis has the reverse problem, since DeepHealth's population-health list names breast, prostate, lung, brain and thyroid. RadNet's EBCD page says patients pay an extra fee for AI mammography.