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.
An FDA advisory panel earlier this year voted to recommend the Somo•v device, which already had FDA clearance for diagnostic use alongside mammography and won CE Mark approval for breast cancer screening in the European Union in September 2010.
Clinical studies supporting the medical device company’s bid for approval found "a statistically significant increase in breast cancer detection when ABUS images were reviewed in conjunction with mammograms, as compared to mammograms alone," according to the FDA.
"Mammography is an effective tool at finding breast cancer, but it doesn’t work equally well in everyone," George Washington University Hospital breast imaging director Dr. Rachel Brem said in prepared remarks. "Recently completed studies demonstrated with the addition of ABUS we find about 30% more cancers in women who have normal mammogram, normal physical examination and dense breasts. For the more than 40% of women who have dense breasts, this is a significant advancement in their breast healthcare."