FDA OKs First Ultrasound Imaging System for Dense Breasts
TUESDAY, Sept. 18 -- The U.S. Food and Drug Administration has approved the first ultrasound device to detect breast cancer in women with dense breast tissue, for use along with standard mammography for women with no symptoms of breast cancer, the agency announced Tuesday.
About 40 percent of women have dense breasts, which can make standard mammograms more difficult to interpret, according to the U.S. National Cancer Institute. Dense breasts have more connective and glandular tissue than less-dense breasts, which contain more fatty tissue.
On regular mammograms, dense breast tissue appears as solid white areas -- and so do tumors. Smaller tumors may be hidden by dense breast tissue, possibly delaying cancer detection, the FDA said in a news release.
Using high-frequency sound waves and computer analysis, however, ultrasound can detect tumors even in dense breasts. The somo-v Automated Breast Ultrasound System (ABUS), with a specially shaped transducer, can scan an entire breast and produce several images for physician review in about a minute, according to the FDA.
Approval came following a study of 200 healthy women with dense breasts and negative mammograms (ones that did not show cancer). Board-certified radiologists reviewed mammograms alone or along with ABUS images. Significantly more breast cancers were detected when ABUS and mammograms both were used, the agency said.
"A physician may recommend additional screening using ultrasound for women with dense breast tissue and a negative mammogram," said Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA's Center for Devices and Radiological Health. "The somo-v ABUS is a safe and effective breast ultrasound tool when such screening is recommended."
Breast cancer is the second leading cancer-related cause of death among American women. Nearly 227,000 women will be diagnosed with breast cancer this year, and more than 39,500 will die from the disease.
U-Systems Inc., based in Sunnyvale, Calif., markets the ultrasound device.
The American Cancer Society explains the importance of early breast cancer detection.
Posted: September 2012