FDA Clears CureMetrix's cmAngio 2.0, Introducing BAC Quantification and Age-Based Context

New release introduces BAC quantification, age-based context, enhanced reporting, and seamless integration.

SAN DIEGO, CA, UNITED STATES, August 17, 2026 /EINPresswire.com/ -- CureMetrix, a healthcare technology company applying artificial intelligence to medical imaging, today announced that cmAngio^® 2.0, the latest evolution of its AI software for Breast Arterial Calcification (BAC) detection on screening mammograms has received 510(K) clearance from the U.S. FDA.

The clearance comes at a time of growing clinical momentum around BAC, which is now recognized as a clinically relevant finding in the 2025 ACR BI-RADS^® Atlas and the subject of new reporting requirements, including first-of-its-kind Maryland legislation requiring patient notification of BAC findings. These developments underscore the need for consistent, standardized BAC assessment and reporting.

cmAngio 2.0 builds upon BAC detection by introducing quantitative BAC measurement, age-based contextualization, and BAC prevalence information based on age-matched peers. Together, these enhancements provide physicians with more meaningful information from the same screening mammogram, without requiring additional imaging, radiation, appointments, or procedures.

BAC is an incidental finding visible on routine screening mammograms. As clinical awareness continues to grow, physicians are increasingly seeking a simple, safe, fast and effective tool that helps consistently and objectively detect, quantify, and communicate BAC findings. cmAngio 2.0 delivers this to physicians proactively managing the health of women.

What's New with cmAngio 2.0
Built from direct physician feedback, cmAngio 2.0 introduces new capabilities designed to provide greater context, improve reporting, and simplify integration.
BAC Quantification. Measures BAC extent in the mammogram.
Age-Based BAC Percentile. Compares a patient's BAC findings to the diverse CureMetrix Reference Library of more than 170,000 studies, providing meaningful age-based context for interpretation.
Age-Based BAC Prevalence. Reports BAC prevalence, helping physicians better understand BAC prevalence across all women represented in the Reference Library.


“Our CureMetrix team has worked with exceptional dedication to reach this important milestone. This FDA clearance for cmAngio 2.0 represents a significant advancement for women’s health” said Navid Alipour, CEO of CureMetrix.

"The conversation around Breast Arterial Calcification has changed dramatically over the past few years," said Kevin Harris, President of CureMetrix. "Physician awareness of the importance of BAC reporting and patient demand for this information is creating a new nexus in proactively managing patient health. cmAngio 2.0 represents a seismic shift in the depth of information physicians now have to drive meaningful conversations with their patients and proactively impact women’s health long-term."

Proven Performance
cmAngio is a proprietary AI-based Software as a Medical Device (SaMD) that analyzes standard full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) screening images. In validation testing, cmAngio demonstrated an Industry-leading AUC of 0.98-0.99 across DBT and FFDM and all breast densities, in women ages 40-90, on GE and Hologic with results automatically returned in minutes.
The software installs in under an hour, integrates with any DICOM-compliant viewer, and requires no additional procedures for the interpreting physician.

Availability
cmAngio 2.0 is available to imaging centers and healthcare facilities throughout the United States. Existing customers can contact their CureMetrix representative regarding upgrade timelines. Providers can also visit www.CureMetrix.com to explore the new capabilities, access resources, and request a demonstration.

CureMetrix
CureMetrix
info@curemetrix.com
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