The first ultrasound device designed to help detect cancer in women with dense breasts, who often aren’t diagnosed until they are experiencing more advanced stages of the disease, was approved by U.S. regulators.
The Food and Drug Administration cleared Sunnyvale, California-based U-Systems Inc.’s somo-v ABUS in combination with standard mammography in women who have a negative mammogram and no symptoms of breast cancer, the agency said today in a statement. The device from the closely held company can scan the entire breast in about one minute.
The National Cancer Institute estimates 40 percent of women who undergo mammography, a low-dose X-ray, have dense breasts. Dense breasts have larger amounts of connective and glandular tissue, making it more difficult to interpret whether cancer is present using a mammogram, the FDA said. The U-Systems’ device would be used as an additional test after a mammogram, the agency said.
Breast cancer is the second-leading cause of cancer-related death among women. An estimated 227,000 women will be diagnosed with the disease in 2012 and almost 40,000 will die, the FDA said.