The Somo•v ABUS is the only automated system in the U.S., Canada and 27 European Union countries indicated for use in combination with standard mammography for asymptomatic women with dense breast tissue.
The companies did not diclose the financial terms of the acquisition.
Sunnyvale, Calif.-based U-Systems landed expanded FDA approval for its Somo•v ABUS in September 2012 for dense breast tissue screening. The device already had clearance for diagnostic use alongside mammography and has had CE Mark approval since September 2010.
“The combination of U-Systems, Inc. and GE Healthcare uniquely positions GE to offer U.S. healthcare providers and their patients the most comprehensive portfolio of breast care innovations on the market – from screening to diagnosis to monitoring,” GE Healthcare president & CEO Tom Gentile said in prepared remarks. “In addition to digital mammography and breast MR, GE can now offer breast screening ultrasound technology to our customers to help in early detection – which provides for more treatment options.”
U-Systems’ specially shaped system can automatically scan the entire breast in about 1 minute, producing several images for review. The device was designed specifically with a high-volume screening environment in mind, according to the company.