Sunnyvale, CA-based U-Systems has completed a $6.5 million funding round. The additional capital came from existing U-Systems investors and affiliates, including iD SoftCapital Group, Lumira Capital, PIIH, Radius Ventures and Sycamore Ventures.
U-Systems is developing automated breast ultrasound systems. This funding will help the company complete its PMA submission to the FDA, wrap up the SOMO•INSIGHT clinical study and continue the development of the next generation automated breast ultrasound system, says Ron Ho, company president and CEO, in a statement.
The SOMO•INSIGHT study will enroll up to 20,000 patients at sites in the U.S. to determine the sensitivity of mammography and somo•v Automated Breast Ultrasound Systems together, compared with mammography alone for women with dense breast tissue.
Last fall, the company it received approval to market its breast ultrasound system as an adjunct to mammography in the EU, according to the Silicon Valley Business Journal.
- see the U-Systems release