Ultrasound developer U-Systems of Sunnyvale, CA, has received approval to market its somo.v automated breast ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in the European Union.
The clearance includes the following indication: "The intended use of the somo.v ABUS system is to provide a significant increase in breast cancer detection and sensitivity of interpreting physicians in diagnosing symptomatic and screening asymptomatic women as an adjunct to mammography."
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U-Systems adds site to clinical study, January 20, 2010
U-Systems rolls out somo.v upgrade, December 2, 2009
U-Systems signs California hospital for study, October 29, 2009
U-Systems adds to clinical study, July 13, 2009
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