An FDA panel unanimously recommended approval of U-Systems’ somo
•v® Automated Breast Ultrasound system for breast cancer screening for women with dense breasts.
An FDA panel this week unanimously recommended approval of what would become the first ultrasound device in the U.S. approved for breast cancer screening.
U-Systems’ somo•v® Automated Breast Ultrasound (ABUS) system is currently FDA-cleared for diagnostic use as an adjunct to mammography. The company’s premarket approval application, which appears headed for approval, would make the technology available for screening for asymptomatic women with dense breast tissue.
The FDA is not bound by the recommendations of its Radiological Devices Panel, but usually follows their advice.
Studies have shown that dense breast tissue increases the risk of breast cancer up to four to six times, according to U-Systems, and also makes cancer harder to detect using mammography. The company sited one study in the New England Journal of Medicine that showed 35 percent o f breast cancer goes undetected by mammography in women with dense breasts.
“Mammography is an effective tool at finding breast cancer, but it doesn’t work equally well in everyone. In women with dense breasts, we can’t see over a third of breast cancers, so we need other technologies, other approaches,” Rachel Brem, MD, director of breast imaging at The George Washington University Hospital in Washington, D.C., said in a statement.
Ron Ho, president and CEO of U-Systems, noted that at least 40 percent of women in the U.S. have dense breast tissue. “If the FDA approves the somo•v PMA,” he said in a statement, “this important adjunctive screening tool for women with dense breasts has the opportunity to become widely available in clinical practice.”