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Volpara Solutions Receives FDA Clearance for Volpara Density Maps

Volpara Health – Published on January 14, 2016

New Era in Quantitative Imaging, Volpara Density Maps Display True Breast Density, True Breast Size

WELLINGTON, New Zealand, January 14, 2016 – Volpara Solutions, the leading provider of automated breast density assessment and quantitative breast imaging tools, announced today that it has received a new 510(k) clearance from the U.S. Food & Drug Administration (FDA) for Volpara Density Maps, a new solution designed to help radiologists address the requirement in the BI-RADS 5th Edition Atlas to provide “an overall assessment of the volume of attenuating tissues in the breast, to help indicate the relative possibility that a lesion could be obscured.”

Volpara Density Maps present the 3D quantitative volumetric information created by the VolparaDensity algorithm in a 2D image that is available as an additional DICOM secondary capture image. Going beyond the measurement of the area of dense tissue, VolparaDensity measures the compressed thickness and volume of dense tissue, which enables the software to highlight specific parts of the breast tissue that are especially dense, including marking the densest 1-cm2 region of the image that might warrant closer inspection due to the masking risk.

VolparaDensity results have been clinically validated in independent studies to correlate to mammography sensitivity.1 Results of the study “Quantifying the Potential Masking Risk of Breast Density in Mammographic Screening,” conducted by researchers from Elizabeth Wende Breast Care (EWBC), demonstrated that VolparaDensity captures the potential masking risk of breast density more precisely compared to the widely used BI-RADS density categories. Additionally, several studies using Volpara Density Maps presented at RSNA 2015 indicate promise for identifying those women at risk of a masked cancer. In the study, “How Can We Identify Women at Risk for a Masked Cancer, Who May Benefit from Supplemental Screening?,” researchers from Nijmegen used novel masking measures derived from density maps to help identify women at risk of a masked cancer.

Beyond masking risk, “For Presentation” images used for cancer detection are often displayed zoomed in, with heavy image processing, making it difficult to judge breast density, especially density changes over time. Volpara Density Maps are designed show true breast density at true size, providing a standardized means of visually assessing which regions of dense tissue change over time.

Volpara recently announced another 510(k) clearance from the FDA for VolparaDensity™, the benchmark in breast density assessment and clinically correlated to both the sensitivity of mammography and the risk of developing cancer. This clearance covered VolparaDensity version 3.1, which has been specifically designed to correlate to the Fifth Edition of the BI-RADS Atlas from the American College of Radiology (ACR). VolparaDensity v3.1 is the first density assessment tool available clinically for use with digital breast tomosynthesis data sets from Hologic, GE and Siemens tomosynthesis systems.

“Representing a new era in quantitative analysis in breast imaging, Volpara Density Maps are the newest entry in Volpara Solutions’ continually evolving and highly innovative suite of volumetric breast imaging tools that are designed to enhance clinical decision-making, workflow and the early detection of breast cancer,” said Ralph Highnam, Ph.D., CEO, Volpara Solutions. “Volpara Density Map images are designed to optimize and standardize the presentation of dense breast tissue, rather than the high-contrast features associated with cancer. Displaying true breast size and true density, this provides radiologists with the best means of visually assessing which regions of dense tissue present a masking risk and supports temporal comparison to identify changes over time.”

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 4th and 5th Editions of the BI-RADS Atlas from the ACR. Volpara Solutions technology is currently in use in 33 countries, and more than 9 million women have had their breast density analyzed using VolparaDensity.

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. 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