Ultrasound developer U-Systems has received a medical device license from the Medical Devices Bureau of Health Canada to sell and market its somo.v automated breast ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in Canada.
The license approves somo.v for use as an adjunct to mammography to provide physicians with enhanced sensitivity for breast cancer detection in diagnostic symptomatic and screening asymptomatic women, according to U-Systems.
In addition to Canada, somo.v is approved for breast cancer screening in the 27 European Union countries. The device also has received clearance by the U.S. Food and Drug Administration (FDA) for adjunctive diagnostic use with mammography in the U.S.
