U-Systems, Inc., a Sunnyvale, CA-based developer of automated breast ultrasound technology, completed a $6.5m funding round.
Backers in the round include existing investors and affiliates iD SoftCapital Group, Lumira Capital, PIIH, Radius Ventures, and Sycamore Ventures.
The company intends to use the funds to complete both Pre-Market Approval (PMA) submission to the U.S. Food & Drug Administration (FDA), and the SOMO-INSIGHT Clinical Study, and to continue development of the automated breast ultrasound system, which is 510(k) cleared, for use as an adjunct to mammography and has CE mark approval in Europe.
The SOMO•INSIGHT study has enrolled up to 20,000 women to determine the sensitivity of mammography and somo•v Automated Breast Ultrasound Systems (ABUS) together, compared to mammography alone for women with dense breast tissue.
U-Systems is led by president and CEO Ron Ho.