cmAngio®
Simple. Safe. Fast. Effective.
The first FDA-cleared, AI-based SaaS solution that detects breast arterial calcifications (BAC) on standard mammograms — with an AUC of .98 across FFDM and DBT1. Turns a mammogram into a 2-for-1 exam: breast cancer screening and BAC detection in one visit.
Results in minutes. Read in seconds.
No new radiation for the patient. No new procedures for the radiologist. Results may be used for further patient management at the independent discretion of the interpreting physician.
1 / 9
400
Live in over 400 sites across the US
17%
Average BAC Present cases seen across all sites
0.98
AUC across DBT and FFDM cases
Understanding Breast Arterial Calcifications
Breast Arterial Calcifications are medial calcifications, different from intimal calcifications, of varying attenuation and length along the walls of the arteries and are currently considered a benign incidental finding in screening mammograms.
Among women who have had screening mammograms, the prevalence of BAC varies from around 12 to 25%2,3. However, less than 5% of BAC in mammograms are reported.
There is no established guideline at a national level for identifying, evaluating, and reporting BAC, leading to inconsistent practices across different institutions and generally low rates of reporting.
cmAngio Key Features
Built for clinical workflows with flexibility, security, and ease of integration.
Adjustable Operating Point
Adjustable operating point to meet clinical goals and workflow preferences.
FFDM & DBT Processing
Processes both Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) For Presentation exams from GE and Hologic.
Easy Integration
cmAngio easily ties into existing radiology tools and clinical workflow.
Automated Processing
BAC segments are automatically localized, marked and displayed on scorecard for review.
Batch Read Ready
Results are returned in minutes and can be read in seconds. Cleared on screening mammograms for women aged 40-90.
All Densities
Demonstrated performance across all breast densities.
Easy to Implement
4-WEEK IMPLEMENTATION
Week 1
Foundation & Alignment
Week 2
Technical Deployment
Week 3
Operational Readiness
Week 4
Go-Live
cmAngio Platform Components
All customized for your practice
Regulatory Timeline
FDA clearance and ANVISA notifications support cmAngio's growing global presence.
V1.0 — K232367
October 2023
Initial FDA 510(k) clearance for breast arterial calcification detection and localization on FFDM and DBT for Hologic Image Acquisition Systems.
V1.0 — NOTIFICATION No. 81464750139
March 2024
Brazilian Health Regulatory Agency clearance for commercial distribution in Brazil.
V1.6 — K250754
April 2025
Expanded clearance to support GE Image Acquisition Systems.
V1.6 — NOTIFICATION No. 81464750139
April 2026
Updated ANVISA notifications for expanded modality support and commercial availability.
V2.0 — 510(k) Pending
Expected 2026
Next-generation platform with expanded features and advanced reporting capabilities.
BAC Detection and Localization Starts Here
See how cmAngio can unlock BAC insights from existing mammography workflows, empowering care teams with actionable detection data.
Request cmAngio Demo
Fill out the form below and our team will get back to you within 24 hours to schedule your personalized demo.
Or schedule directly with our National Account Team: Book a demo now
References
- [1]FDA 510(k) K250754 — cmAngio AI-based software for breast arterial calcification detection and localization. Performance data on file.
- [2]Loberant et al. "Prevalence and Degree of Breast Arterial Calcifications on Mammography: A Cross-sectional Analysis." Journal of Clinical Imaging Science, vol. 3, 27 Sep. 2013. doi:10.4103/2156-7514.11901
- [3]Iribarren et al. "Breast Arterial Calcification: a Novel Cardiovascular Risk Enhancer Among Postmenopausal Women." JACC: Advances, 2022.