FDA Clears Updated AI Mammography Software for Breast Arterial Calcification Detection

The Food and Drug Administration (FDA) has issued a 510(k) clearance for the cmAngio 2.0 software, which utilizes AI to facilitate detection of breast arterial calcification (BAC) on full-field digital mammography and digital breast tomosynthesis (DBT).

CureMetrix, the developer of cmAngio 2.0, said the updated software offers a variety of new features including:

• quantification of BAC;

• age-based BAC percentile, which offers age-based context derived from a comparison of patient findings to the company’s reference library of over 170,000 mammography studies; and

• age-based BAC prevalence, which is based on reported age-based prevalence data from the aforementioned CureMetrix reference library.

The company added that the software can be installed in less than hour and has demonstrated up to a 99 percent AUC for detecting BAC regardless of breast density.

“The conversation around breast arterial calcification has changed dramatically over the past few years,” noted Kevin Harris, the 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.”