GE Healthcare, a division of General Electric based in the United Kingdom, announced in a press release that it has acquired U-Systems. U-Systems is a medical device manufacturer that recently won expanded United States FDA approval for a first-in-class ultrasound breast cancer screening device.
U-Systems’ Somo•v ABUS is approved for use in 27 E.U countries, the U.S. and Canada. The Somo•v ABUS uses dense-tissue mammogram technology to deliver automated ultrasounds. The device is indicated for use traditional mammography techniques. Since some forms of breast cancer may be asymptomatic, it can be difficult for healthcare providers to determine if dense breast tissue is malignant. With the Somo•v ABUS, healthcare providers can quickly and easily determine the breast health of asymptomatic women.
The medical device company received expanded FDA approval for the Somo•v ABUS product line in September of this year. The device had already been approved for use with traditional mammography. The device has also had CE Mark approval in the E.U for over two years.