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"The Food and Drug Administration (FDA) has approved the somo*v® Automated Breast Ultrasound System (ABUS) for breast cancer screening in women with dense breast tissue, as an adjunct to a negative mammography. ABUS has been marketed in the United States since 2005 as a diagnostic tool. It is the first system of its kind approved by the FDA for the expanded indication of breast cancer screening.1,2

This expanded approval is based primarily on a study demonstrating that somo*v ABUS scanning following digital mammography screening, compared with screening mammogram alone, significantly improved sensitivity for physician readers without significantly reducing specificity. The large-scale, prospective, multicenter somo*v INSIGHT trial (NCT00816530) is ongoing and will be completed by the end of 2012; the results are expected to be presented at the December 2012 Radiological Society of North America meeting"

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