U-Systems has received Health Canada approval to market and sell its somo•v Automated Breast Ultrasound System (ABUS) as an adjunct to mammography for screening asymptomatic women for breast cancer in Canada.
Approval 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.”
“The somo•v Automated Breast Ultrasound System is not intended as a replacement for mammography,” said Ron Ho, president and CEO of Sunnyvale, Calif.-based U-Systems.
somo•v ABUS automates the breast ultrasound imaging process, and somo•viewer Advanced 3D Workstation enables review and archive of patient exams.
U-Systems is the sponsor of the national SOMO•INSIGHT Clinical Study, which is designed to evaluate whether digital mammography in combination with somo•v ABUS is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with dense breast tissue. More than 15,000 women have participated in the study which is actively recruiting up to 20,000 women at multiple breast imaging centers across the U.S.