News | November 18, 2010

FDA Clears Breast Imaging Software for Calculating Density

November 18, 2010 – A breast imaging software for use with digital mammography has received clearance from the U.S. Food & Drug Administration (FDA).

Automatically computing volumetric breast tissue density from screening mammograms, Volpara software assists radiologists by providing objective, automatic and robust measurement of volumetric breast tissue density. Cleared for use with digital mammography systems, Volpara is currently available for Hologic and GE digital mammography systems, with other systems undergoing validation. Volpara, a subsidiary of Matakina Technology Ltd. of New Zealand, is responsible for commercial operations in the United States.

Breast tissue density has not only been linked to an increased risk of breast cancer, it also decreases the sensitivity of the mammogram and thereby may impact early detection. Several large studies have confirmed that as tissue density increases, the accuracy of mammography decreases. Since both dense breast tissue and cancer appear white on a mammogram, finding cancers can be analogous to looking for a snowball in a snow storm.

Radiologists currently use the Breast 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 magnetic resonance imaging (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,” said Martin J. Yaffe, Ph.D., of the Sunnybrook Health Sciences Centre in Toronto, a renowned physicist responsible for pioneering work on quantitative breast imaging.

Using digital images and information captured in every mammographic exam, Volpara applies an algorithm developed by some of the world’s top imaging scientists, using new developments in imaging physics.

For more information: www.volparadensity.com

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