CureMetrix, a healthcare technology company applying AI to medical imaging, has received 510(K) clearance from the US FDA for its cmAngio 2.0, the latest evolution of its AI software for Breast Arterial Calcification (BAC) detection screening on mammograms
The clearance comes as clinical momentum grows around BAC, which is recognised as a clinically relevant finding in the 2025 ACR BI-RADS Atlas and the subject of new reporting requirements, including Maryland legislation requiring patient notification of BAC findings. These developments emphasise the need for consistent, standardised BAC assessment and reporting.
cmAngio 2.0 expands on BAC detection by introducing quantitative BAC measurement, age-based contextualisation, and BAC prevalence information based on age-matched peers. These enhancements provide more meaningful information from the same screening mammogram, without additional imaging, radiation, appointments, or procedures.
BAC is an incidental finding visible on routine screening mammograms. As clinical awareness grows, physicians are seeking a simple, safe, fast, and effective tool that helps consistently and objectively detect, quantify, and communicate BAC findings. cmAngio 2.0 provides this to physicians proactively managing women’s health.
What’s new
Developed using direct physician feedback, cmAngio 2.0 introduces new capabilities that provide greater context, enhance 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 over 170,000 studies, providing meaningful age-based context for interpretation
- Age-based BAC Prevalence: reports BAC prevalence, helping physicians to better understand BAC prevalence across all women represented in the Reference Library.
Navid Alipour, CEO of CureMetrix, said, “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.”
Kevin Harris, president of CureMetrix, said, “The conversation around Breast Arterial Calcification has changed dramatically over the past few years. 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 an AI-based software as a medical device (SaMD) that analyses standard full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) screening images.
In validation testing, cmAngio demonstrated an 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.
