FDA to weigh ultrasound screening tool for women with dense breasts
An FDA Advisory Panel is scheduled to decide whether to recommend approval of a new breast cancer screening indication for somo•v Automated Breast Ultrasound (ABUS) System on April 11.
If approved by the FDA, somo•v would be approved for use as an adjunct to mammography for women with dense breasts. Studies have shown the use of ABUS finds about 30 percent more cancers in women who have a normal mammogram, a normal physical examination and dense breasts, according to Sunnyvale, Calif.-based U-Systems.
More than 40 percent of women in the U.S. have dense breasts.
For more about screening breast ultrasound, please read "Breast Ultrasound Screening Marches into Practice," published November 2011, in Health Imaging.
If approved by the FDA, somo•v would be approved for use as an adjunct to mammography for women with dense breasts. Studies have shown the use of ABUS finds about 30 percent more cancers in women who have a normal mammogram, a normal physical examination and dense breasts, according to Sunnyvale, Calif.-based U-Systems.
More than 40 percent of women in the U.S. have dense breasts.
For more about screening breast ultrasound, please read "Breast Ultrasound Screening Marches into Practice," published November 2011, in Health Imaging.