FDA Expands Clearance for AI Mammography Software for Breast Arterial Calcification Detection
The additional FDA 510(k) clearance for the AI-powered cmAngio platform covers use of the software for GE HealthCare mammography systems.
The Food and Drug Administration (FDA) has issued an expanded 510(k) clearance for cmAngio, an artificial intelligence (AI)-enabled software that facilitates detection of breast arterial calcification (BAC) on full-field mammography and digital breast tomosynthesis (DBT).1
Previously garnering FDA clearance for use on Hologic mammography platforms in October 2023, the expanded clearance for cmAngio allows clinicians to employ the AI software with GE HealthCare mammography systems, according to CureMetrix, the manufacturer of cmAngio.
The artificial intelligence (AI)-enabled software cmAngio, which facilitates detection of breast arterial calcification (BAC) on full-field mammography and digital breast tomosynthesis (DBT), has garnered an expanded FDA clearance for use with GE HealthCare mammography systems. (Photo courtesy of CureMetrix.)
Researchers have demonstrated that detection of BAC in mammography exams for postmenopausal women is associated with a greater than 50 percent higher likelihood of stroke or heart disease.2
“By adding GE HealthCare to our list of validated imaging platforms, cmAngio expands its commercial footprint, reaching more radiologists in practices where GE is the primary mammography platform used,” noted Kevin Harris, the president of CureMetrix. “This broader compatibility supports our commitment to enhancing access for BAC detection across diverse clinical environments while increasing assurance that patients are receiving the highest standard of care available from screening mammography.”
References
1. CureMetrix. CureMetrix expands cmAngio with FDA clearance for version 1.6, now validated on Hologic and GE platforms. EINPresswire. Available at: https://www.einpresswire.com/article/803238004/curemetrix-expands-cmangio-with-fda-clearance-for-version-1-6-now-validated-on-hologic-ge-platforms . Published April 15, 2025. Accessed April 16, 2025.
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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