SUNNYVALE, Calif. – U-Systems, the leader in automated breast ultrasound, announced todaythat the somo-v Automated Breast Ultrasound (ABUS) system has been approved by the U.S. Food and Drug Administration’s (FDA) for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue.With the approval, the somo-v ABUS systembecomes the only device approved specifically for screening women with dense breasts.

      “The FDA approval of the somo-v ABUS device is an exciting and important development in the detection of early, curable breast cancer. The use of somo-v for screening women with dense breasts will undoubtedly have a positive impact for women currently being underserved by mammography,” said Rachel Brem, M.D., Director of Breast Imaging at The George Washington University Hospital, Washington D.C.

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      “Mammography is an effective tool at finding breast cancer, but it doesn’t work equally well in everyone. Recently completed studies demonstrated with the addition of ABUS we find about 30 percentmore cancers in women who have normal mammogram, normal physical examination and dense breasts. For the more than 40 percent of women who have dense breasts, this is a significant advancement in their breast healthcare.”

      FDA approval comes after a Radiological Devices Panel of the FDA’s Medical Devices Advisory Committee unanimously recommended approval of U-Systems’ premarket approval (PMA) application in April. The somo-v ABUS systemis the only ultrasound device approved for breast cancer screening in the United States, Canadaand 27 European Union countries as an adjunct to mammography for asymptomatic women with dense breast tissue.

      “We are proud to announce that the somo-v ABUS system has received FDA approval for breast cancer screening and U-Systems can offer radiologists and breast imaging experts an important new tool to improve early detection in women with dense breasts,”said Ron Ho, President and CEO of U-Systems. “Enabling radiologists to use the information obtained from mammography and integrate that with the information obtained with ultrasound, leverages the potential of ABUS in a screening environment to find the 30 percent additional cancers that would not have been found with mammography alone. Research shows that ABUS can help find cancer in women with dense breasts, and that the cancers are smaller and earlystage. With formal approval, we are moving rapidly from development to commercialization and look forward to making the somo-v ABUS system more widely available across the United States.”