The FDA approves U-Systems' Somo•v breast cancer detection system, the 1st ultrasound system indicated for dense breast tissue.
The FDA approved U-Systems ' Somo•v breast ultrasound system, 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.
Dense breast tissue, which occurs in nearly half of women, increases the risk of breast cancer up to 4-to-6 times and can also make the cancer more difficult to detect with mammography, some studies have shown.
U-Systems' specially shaped system can automatically scan the entire breast in about 1 minute, producing several images for review, according to the FDA notice. The device was designed specifically with a high-volume screening environment in mind, according to the company.