CureMetrix has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for cmAngio 2.0, the latest version of its AI-based software for Breast Arterial Calcification (BAC) detection on screening mammograms.
The update introduces BAC quantification, age-based BAC percentile scoring compared against a reference library of more than 170,000 studies, and age-based BAC prevalence reporting, the company said. In validation testing, cmAngio 2.0 demonstrated an area under the curve of 0.98 to 0.99 across digital breast tomosynthesis and full-field digital mammography in women ages 40 to 90, on GE HealthCare and Hologic systems, according to CureMetrix.
The software integrates with any DICOM-compliant viewer and is available to imaging centers and healthcare facilities in the U.S., the firm said.
