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Mammography News: FDA Clears AI Software for Breast Arterial Calcification Detection


Utilized in conjunction with screening digital mammography or digital breast tomosynthesis (DBT), the artificial intelligence (AI)-powered software cmAngio may help detect and localize breast arterial calcification (BAC), an incidental finding that has been linked to an elevated risk for heart disease and stroke.

The Food and Drug Administration (FDA) has granted 510(k) clearance for cmAngio®, an artificial-intelligence (AI)-enabled software that facilitates the detection of breast arterial calcification (BAC) through assessment of full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT).1

While BAC is a common incidental finding on mammograms, less than 5 percent of BAC are reported, according to CureMetrix, the developer of cmAngio. A recent study found that postmenopausal women with BAC detected on mammography exams are 51 percent more likely to have a stroke or develop heart disease.2

“There is a growing consensus among the medical community that the presence of breast arterial calcifications should be included on mammogram reports,” said Lisa Watanabe, M.D., FACR, the chief medical officer at CureMetrix. “The cmAngio software will be a tremendous aid for radiologists like myself in providing timely and accurate results for BAC detection. I am hopeful that cmAngio will someday be widely incorporated in breast imaging practices as a useful application of artificial intelligence that can enhance physician decision-making, reporting, and patient care."

CureMetrix emphasized that cmAngio facilitates identification and reporting of BAC without additional procedures and increased radiation risk for patients. The AI software has demonstrated efficacy for women of varying breast density, according to CureMetrix.

The company adds that cmAngio is compatible with DICOM-compatible viewers and can be installed in less than an hour.


1. CureMetrix. CureMetrix receives FDA clearance for cmAngio®, first-of-its-kind solution for detecting breast arterial calcification. EIN Presswire. Available at: https://www.einpresswire.com/article/661554753/curemetrix-receives-fda-clearance-for-cmangio-first-of-its-kind-solution-for-detecting-breast-arterial-calcification#:~:text=SAN%20DIEGO%2C%20CA%2C%20UNITED%20STATES,BAC)%20detection%20and%20localization%20software. Published October 16, 2023. Accessed October 17, 2023.

2. Iribarren C, Chandra M, Lee C, et al. Breast arterial calcification: a novel cardiovascular risk enhancer among postmenopausal women. Circ Cardiovasc Imaging. 2022;15(3):e013526.

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