U-Systems has received CE mark approval to market somo.v Automated Breast Ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in the European Union.
The approval was based on extensive clinical evidence that the somo.v ABUS system increases breast cancer detection and sensitivity of interpreting physicians in diagnosing symptomatic and screening asymptomatic women as an adjunct to mammography.
U-Systems is currently sponsoring the Somo·Insight clinical study, designed to evaluate whether digital mammography in combination with the somo.v ABUS system is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with greater than 50% dense breast tissue.
U-Systems president and CEO Ron Ho said that the somo.v ABUS represents a major advancement in breast health for women as study after study, have demonstrated a need for additional tools to improve the early detection of breast cancer, particularly in women with dense breast tissue which impacts detection and carries an increased risk of breast cancer.
“The somo.v ABUS is not intended as a replacement for mammography, which remains the most effective screening tool for many women. However, we have strong scientific evidence that for women with dense breast tissue, supplementing mammograms with somo.v ABUS can substantially increase breast cancer detection,” Ho said.