* Increase in sensitivity was associated with a decrease in overall specificity.
1. 55% increase in invasive cancer detection: Brem RF, Tabár L, et.al. Assessing Improvement in Detection of Breast Cancer with Three-dimensional Automated Breast US in Women with Dense Breast Tissue: The SomoInsight Study. Radiology. 2015 Mar; 274(3): 663-73.
2. Mammography may miss over one third of cancers in dense breasts. Mandelson et al. Breast density as a predictor of mammographic detection: comparison of interval- and screen-detected cancers. J Natl Cancer Inst 2000; 92:1081–1087.
3. Over 40% of women in the United States have dense breast tissue: Pisano et al. Diagnostic Performance of Digital versus Film Mammography for Breast Cancer Screening. NEJM 2005;353:1773
4. Having dense breasts increases the likelihood of a woman developing cancer by 4-6 times. Boyd, N.F. et.al. Mammographic Density and the Risk and Detection of Breast Cancer, N Engl J Med 2007;356:227-36.

Brief Statement
The Invenia ABUS is indicated as an adjunct to mammography or breast cancer screening in asymptomatic women for whom screening mammography findings are normal or benign (BI-RADS® Assessment Category 1 or 2), with dense breast parenchyma (BI-RADS Composition/Density C or D), and have not had previous clinical breast intervention. The device is intended to increase breast cancer detection in the described patient population. The Invenia ABUS may also be used for diagnostic ultrasound imaging of the breast in symptomatic women. Prescription device. See the device manual for detailed information, contraindications, warnings, precautions, potential adverse events.