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News
March 2, 2012 — U-Systems announced the somo•v automated breast ultrasound (ABUS) system is scheduled for review by the Radiological Devices Panel of the U.S. Food and Drug Administration (FDA) on April 11, 2012.
March 02, 2012 
News
November 14, 2011 - U-Systems announced the U.S. Food & Drug Administration (FDA) has cleared the premarket approval (PMA) application for breast cancer screening indication for use for the somo•v Automated Breast Ultrasound (ABUS) system. The system is currently FDA-cleared for diagnostic use as an adjunct to mammography.
November 14, 2011 
Technology
October 21, 2011 — At RSNA 2011, U-Systems will showcase its new Reverse Curve Soft Touch Transducer technology. The system was designed and optimized for use with the U-Systems’ somo•v Automated Breast Ultrasound (ABUS) system.
October 21, 2011 
News
September 15, 2011 - U-Systems, the leader in automated breast ultrasound, announced the first Canadian installation of the somo•v automated breast ultrasound (ABUS) system at VIP Breast Imaging in Toronto. The announcement was made at the Multimodality Detection and Diagnosis of Breast Diseases Conference being held at the Westin Harbour Castle in Toronto, September 6-9. The company also announced an agreement to partner with VIP Breast Imaging as they expand their imaging centers coast-to-coast across Canada.
September 16, 2011 
News
August 18, 2011 – U-Systems announced that it has been granted a medical device license by the Medical Devices Bureau of Health Canada to sell and market the somo•v automated breast ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in Canada. Approval was based on extensive clinical evidence and includes the following indication: “The somo•v ABUS ultrasound device is intended for use as an adjunct to mammography to provide physicians with an increase in the sensitivity of breast cancer detection in diagnostic symptomatic and screening asymptomatic women.”
August 18, 2011 
Technology
May 19, 2011 - U-Systems launched a new transducer technology designed to deliver unparalleled imaging performance and patient comfort. Reverse-Curve Crystal (RCC) Transducer Technology was designed and optimized for use with the U-Systems’ somo•v Automated Breast Ultrasound (ABUS) system. The announcement was made at the 10th Post Graduate Course of the Society of Breast Imaging (SBI) Meeting, in San Antonio, May 18- 21.
May 19, 2011 
News
April 11, 2011 – Are You Dense, a non-profit breast cancer organization, has announced a partnership with U-Systems to increase awareness of dense breast tissue and its significance in the early detection of breast cancer. Are You Dense founder Nancy M.
April 11, 2011 
News
March 14, 2011 – A pivotal ROC reader study for automated breast ultrasound cancer screening has been completed. The multi-reader, multi-case (MRMC) study evaluated the sensitivity of the somo•v Automated Breast Ultrasound (ABUS) together with a screening mammogram in detecting breast cancer in women with dense breast tissue
March 14, 2011 
News
October 11, 2010 — Jefferson Radiology, the largest radiology private practice group in Connecticut, has installed the somo•v Insight Class automated breast ultrasound (ABUS) system. The system is designed to improve early detection of cancer in women with dense breast tissue.
October 11, 2010
News
September 15, 2010 — Approval has been given to market the somo•v automated breast ultrasound system (ABUS) as an adjunct to mammography for screening asymptomatic women for breast cancer in the European Union.
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