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Volpara Solutions Awarded New FDA Clearance for Automated Breast Density Assessment Using ACR BI-RADS 5th Edition Categories

Press releases may be edited for formatting or style | November 24, 2015

Breast density has not only been linked to an increased risk of breast cancer, it also dramatically impacts early detection. Several large studies have confirmed that as density increases the accuracy of mammography decreases. According to a study published in the New England Journal of Medicine, 35 percent of breast cancer goes undetected by mammography in women with dense breasts and density masks appearance of tumors. Since both dense breast tissue and cancer appear white on a mammogram, it is analogous to looking for a snowball in a snow storm.

Cleared by the FDA, HealthCanada, the TGA and CE-marked, VolparaDensity is in use at breast imaging centers worldwide to help radiologists objectively assess density from digital mammography and tomosynthesis images to determine which women might benefit from additional imaging. Highly correlated to breast MR assessments, VolparaDensity is a reliable tool that automatically generates an objective measurement of volumetric breast density correlated to the ACR (American College of Radiology) BI-RADS breast density categories.

About Volpara Solutions

Founded with the goal of helping radiologists give women the most accurate information possible regarding their breast health, Volpara Solutions is the wholly owned sales and marketing arm of Volpara Health Technologies Limited of New Zealand (formerly Matakina Technology). Cleared by the FDA, HealthCanada, the TGA, and CE-marked, VolparaDensity provides an objective volumetric measure of breast density from both digital mammography and tomosynthesis images. VolparaDensity is part of a suite of quantitative breast imaging tools built on the Volpara Solutions algorithm that allows for personalized measurements of density, patient-specific x-ray dose, breast compression, breast positioning and other factors designed to provide critical insight for breast imaging workflow. For more information, visit www.volparasolutions.com

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Media Contacts:

Chris K. Joseph, Volpara Solutions, 510/435-4031, chris.joseph@volparasolutions.com

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