FDA Approves First Imaging Device For Dense Breasts

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http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319867.htm

FDA Approves First Imaging Device For Dense Breasts.

Bloomberg News (9/19, Edney) reports that the Food and Drug Administration has approved the "first ultrasound device designed to help detect cancer in women with dense breasts." In a press statement, the agency said it cleared Sunnyvale, California-based U-Systems's somo-v Automated Breast Ultrasound System (ABUS) in "combination with standard mammography in women who have a negative mammogram and no symptoms of breast cancer."

        CQ (9/19, Subscription Publication) notes that according to the National Cancer Institute, "about 40 percent of women undergoing screening mammography have dense breasts," which put them at an "increased risk of breast cancer" because detection usually occurs at a "more advanced and difficult to treat stage." In announcing the approval, the FDA "said ultrasound imaging has been shown to be able to detect small masses in dense breasts." The uniquely shaped transducer of the ABUS "can automatically scan the entire breast in about one minute to produce several images for review."

        HealthDay (9/19, Esposito) reports CDRH's Office of In Vitro Diagnostic Device Evaluation and Safety Director Alberto Gutierrez, PhD, noted that physicians generally, "recommend additional screening using ultrasound for women with dense breast tissue and a negative" mammogram reading; and Dr. Gutierrez said the "somo-v ABUS is a safe and effective breast ultrasound tool when such screening is recommended."

        According to MedPage Today (9/19, Gever), approval was based on a "trial in which radiologists examined mammograms from 200 asymptomatic women with dense breasts, with and without supplementary ultrasound images from the somo-v ABUS device. Results indicated that use of the ultrasound images increased breast cancer detection by about 30%." As part of the approval, the FDA said women who have "had a previous breast intervention such as surgery or biopsy would not generally be eligible for screening with the device" because it "might alter the appearance of breast tissue in an ultrasound image."

        HealthImaging (9/19, Fratt) adds that the FDA will also require that U-Systems "provide thorough training for physicians and technologists using the ABUS device" and it has charged the company with providing "each facility with a manual clearly defining system tests required for initial, periodic and yearly quality control measures." Additionally, HealthImaging notes that some states, including "Connecticut, New York, Texas, Virginia and California, have enacted breast density notification legislation, requiring providers to notify women if they have dense breast tissue."