FDA Clears CureMetrix's cmAngio 2.0 for Enhanced BAC Detection

CureMetrix, renowned for integrating artificial intelligence with medical imaging, has announced that its latest AI software, cmAngio 2.0, has received 510(k) clearance from the U.S. FDA. This development marks a significant advancement for detecting Breast Arterial Calcification (BAC) on screening mammograms.

The clearance comes as BAC gains increasing recognition for its clinical relevance, highlighted in the 2025 ACR BI-RADS® Atlas and supported by new reporting mandates, such as Maryland's pioneering legislation that obligates patient notification of BAC findings. The growing emphasis on these assessments underscores the necessity for standardized BAC evaluation and documentation.

CmAngio 2.0 offers several enhancements, including quantitative BAC measurement, age-based contextual information, and BAC prevalence data based on age-matched peers. These features empower physicians to extract valuable insights from a single screening mammogram without additional imaging, radiation, or procedures.

BAC is typically an incidental finding in routine screening mammograms. With rising clinical awareness, there is a strong demand from physicians for tools that consistently and objectively detect, quantify, and report BAC findings. In response, cmAngio 2.0 delivers a user-friendly solution that aligns with proactive approaches in women's health management.

The latest version of cmAngio is built on feedback from physicians and introduces capabilities that enhance context, reporting, and integration. The software measures BAC extent, compares BAC findings to a comprehensive reference library of over 170,000 studies, and reports its prevalence. This enables physicians to gain a deeper understanding of BAC distribution in the population.

Kevin Harris, President of CureMetrix, emphasized the transformed landscape around BAC discussions, acknowledging the heightened physician awareness and patient demand for BAC information. Navid Alipour, CEO of CureMetrix, remarked on the dedication behind achieving this FDA clearance, highlighting its potential impact on women's health.

CmAngio is an AI-based Software as a Medical Device (SaMD) that analyzes full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) images and has demonstrated an industry-leading AUC of 0.98-0.99 in validation tests. The software requires minimal installation time, integrates with any DICOM-compliant viewer, and does not necessitate additional procedures for interpretation.