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FDA Clears Volpara™ Breast Imaging Software for Automatic Calculation of Volumetric Breast Density
Date:11/18/2010

Imaging Reporting and Data System (BI-RADS) system to classify density.  Developed by the American College of Radiology, the density assessment ranges from Category 1 (mostly fat) to Category 4 (extremely dense).  However, the density category assessment is subjective and varies widely among interpreting physicians, even those who are experienced.  Automated, objective, volumetric density assessments, consistently applied, has the potential both for establishing a new and important metric for mammography, and for allowing physicians to compare a patient's volumetric density from year to year.

"With the ability to objectively and accurately measure breast density, we can look at screening women with low and high densities differently rather than one size fits all universal screening programs. For example, it may be a good idea for women with very dense breasts to receive ultrasound or MRI in addition to mammography as part of regular screening. In the future, it may be possible by lowering breast density to reduce breast cancer risk. In this case, it would be helpful to monitor this process by tracking changes in breast density over time. An automated breast density system like Volpara provides quantitative reproducible measurements of breast density and could be useful for both of these purposes," said Prof. Martin J. Yaffe, PhD, of the Sunnybrook Health Sciences Centre in Toronto, and a renowned physicist responsible for pioneering work on quantitative breast imaging.

Volpara provides an easy to implement, objective volumetric assessment of breast tissue density. Using digital images and information captured in every mammographic exam, the system applies a state-of-the-art algorithm developed by some of the world's top imaging scientists using new developments in imaging physics. The robustness of the software provides quantitative reliability, allowing Volpara to be incorporated in both research and with clinical imaging protocols, w
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SOURCE Volpara, Ltd.
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