U-Systems' somo-v Automated Breast Ultrasound System
January 19, 2010 - Automated breast ultrasound system (ABUS) is used as an adjunct to mammography for B-mode ultrasonic imaging of a patient’s breast when used with an automatic scanning linear array transducer. The Radiology Regional Center is recruiting participants for the national clinical research study designed to evaluate whether digital mammography in combination with the ABUS is more sensitive to detecting breast lesions when compared to mammography alone in women with dense breasts.
The initiation of this multi-center study, which intends to recruit over 20,000 women, is an important milestone for U-Systems in evaluating new approaches to improved cancer detection. Screening mammography can be limited in women with dense breasts and these women may have a higher risk of breast cancer. The device used in the study, uses ultrasound (sound waves) at a safe frequency to create images of the breast tissue. Ultrasound may demonstrate cancer not visible with mammography in women who have dense breasts.
“We are pleased to take part in this important study evaluating potential new approaches to the early detection of breast cancer in women with dense breasts, which historically have been difficult to screen,” said Mary Kay Peterson, M.D., director of Women’s Imaging at Radiology Regional Center and principal investigator for the SOMO•INSIGHT clinical study. “We strongly believe that early detection is critical and we are excited to be able to provide women in Southwest Florida with access to cutting edge technology that could potentially detect abnormalities earlier in the fight against breast cancer.”
The U-Systems somo•v Automated Breast Ultrasound System (ABUS) is currently cleared under 510(k). The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient’s breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.
For more information: www.u-systems.com
November 07, 2025 
