FDA clears CureMetrix’s cmAngio 2.0 for BAC detection and reporting

CureMetrix says the U.S. FDA has cleared cmAngio 2.0, its AI software for detecting breast arterial calcification on screening mammograms. The update adds BAC quantification and age-based context as clinicians face new reporting requirements and growing interest in BAC as a heart-health signal.

Why it matters: - BAC is gaining clinical attention as a meaningful finding on screening mammograms. - The 2025 ACR BI-RADS® Atlas now recognizes BAC as clinically relevant. - Maryland has also enacted reporting requirements that include patient notification of BAC findings. - cmAngio 2.0 is designed to help physicians consistently detect, quantify and communicate BAC without extra imaging, radiation, appointments or procedures.

What happened: - CureMetrix announced that cmAngio® 2.0 received 510(k) clearance from the U.S. FDA. - The software is the latest version of CureMetrix’s AI tool for Breast Arterial Calcification detection on screening mammograms. - The company said the update is available to imaging centers and healthcare facilities across the U.S. - Existing customers can contact a CureMetrix representative about upgrade timing. - Providers can also visit CureMetrix’s website to review capabilities, access resources and request a demo.

The details: - cmAngio 2.0 adds quantitative BAC measurement. - The software adds age-based contextualization for BAC findings. - cmAngio 2.0 adds BAC prevalence information based on age-matched peers. - The Reference Library used for comparison includes more than 170,000 studies. - The software is built from direct physician feedback. - CureMetrix said the changes are meant to improve reporting and simplify integration. - cmAngio analyzes standard full-field digital mammography and digital breast tomosynthesis screening images. - Validation testing showed an AUC of 0.98-0.99 across DBT and FFDM, all breast densities, and women ages 40-90. - The software was tested on GE and Hologic systems. - Results are returned automatically in minutes. - The software installs in under an hour. - cmAngio integrates with any DICOM-compliant viewer. - The workflow requires no additional procedures for the interpreting physician.

Between the lines: - The clearance lands as BAC moves from a niche imaging observation toward a more standardized reporting metric. - Age-based percentile and prevalence data give radiologists more context than a simple positive or negative result. - That framing may help physicians explain BAC findings in patient conversations and connect mammography results to broader preventive care. - Navid Alipour, CureMetrix CEO, said the clearance marks a significant advancement for women’s health. - Kevin Harris, CureMetrix president, said rising physician awareness and patient demand are creating a new focus on proactive health management.

What’s next: - Imaging sites can begin adopting cmAngio 2.0 now that FDA clearance is in place. - Current customers are expected to move through upgrade timelines with CureMetrix support. - Wider BAC reporting adoption could increase demand for tools that standardize measurement and interpretation.

The bottom line: - CureMetrix is pushing BAC from an incidental mammogram finding into a quantified, context-rich clinical metric.