EU clears U-Systems breast ultrasound as mammo adjunct
U-Systems has received approval to market its somo.v Automated Breast Ultrasound system (ABUS) as an adjunct to mammography for screening asymptomatic women for breast cancer in the European Union.
According the Sunnyvale, Calif.-based company, the CE Mark includes an indication, stating: “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.”
According the Sunnyvale, Calif.-based company, the CE Mark includes an indication, stating: “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.”