FDA approves breast density evaluation tool
Mammography Regulation and Reimbursement Report, January 1, 2011
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Radiologists have a new tool to help them determine a woman’s breast density. In December 2010, the FDA gave marketing clearance for breast imaging software created by Volpara, Ltd., that calculates breast tissue density based on a woman’s screening mammogram. VolparaTM breast imaging software works by applying an algorithm to the raw digital images to determine volumetric tissue density. The software is currently available for HologicTM and GE digital mammography systems. Other systems are being validated.
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