TUESDAY, Sept. 18 (HealthDay News) -- The first ultrasound device to help doctors detect potential tumors in women with dense breast tissue has been approved by the U.S. Food and Drug Administration.
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About 40 percent of women who get mammogram screenings have dense breasts, which have a high amount of connective and glandular tissue, the FDA said Tuesday in a news release. These women, whom doctors identify with mammography, are at above-average risk of developing breast cancer.
Dense breasts may be seen on mammograms as solid white areas, making it more difficult for doctors to spot potential tumors, the FDA said.
The somo-v Automated Breast Ultrasound System (ABUS) can scan the breast in about one minute to produce several images for review, the agency said.
The device has been approved for women who have had a negative mammogram and no symptoms of breast cancer. Women who have had a prior biopsy or other breast surgery may not be candidates for the new device, since those prior procedures may change breast tissue appearance in an ultrasound, the FDA said.
The device is marketed by U-Systems Inc., based in Sunnyvale, Calif.
-- Scott Roberts
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