September 18, 2012 — The U.S. Food and Drug Administration (FDA) has approved U-Systems' somo•v automated breast ultrasound (ABUS) system for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue. With the approval, the somo•v ABUS system becomes the only device approved specifically for screening women with dense breasts.
“The FDA approval of the somo•v ABUS device is an exciting and important development in the detection of early, curable breast cancer. The use of somo•v for screening women with dense breasts will undoubtedly have a positive impact for women currently being underserved by mammography,” said Rachel Brem, M.D., director of breast imaging at The George Washington University Hospital, Washington, D.C. “Mammography is an effective tool at finding breast cancer, but it doesn’t work equally well in everyone. Recently completed studies demonstrated with the addition of ABUS, we find about 30 percent more cancers in women who have normal mammogram, normal physical examination and dense breasts. For the more than 40 percent of women who have dense breasts, this is a significant advancement in their breast healthcare.”
The approval comes after a Radiological Devices Panel of the FDA’s Medical Devices Advisory Committee unanimously recommended approval of U-Systems’ premarket approval (PMA) application in April. The somo•v system is the only ultrasound device approved for breast cancer screening in the United States, Canada and 27 European Union countries as an adjunct to mammography for asymptomatic women with dense breast tissue.
“Enabling radiologists to use the information obtained from mammography and integrate that with the information obtained with ultrasound, leverages the potential of ABUS in a screening environment to find the 30 percent additional cancers that would not have been found with mammography alone,” said Ron Ho, president and CEO of U-Systems. “Research shows that ABUS can help find cancer in women with dense breasts, and that the cancers are smaller and early stage. With formal approval, we are moving rapidly from development to commercialization and look forward to making the somo•v ABUS system more widely available across the United States.”
Dense breast tissue not only increases the risk of breast cancer up to four to six times, but also makes cancer more difficult to detect using mammography, according to multiple large studies. One study, published in the New England Journal of Medicine, showed 35 percent of breast cancer goes undetected by mammography in women with dense breasts, as density masks the appearance of tumors (Boyd, et al, NEJM 2007:356:227-36M). As breast density goes up, the accuracy of mammograms goes down.
Issues with manual breast ultrasound screenings have been the large amount of time these exams take, the need for a highly qualified sonographer, and the variability in how an exam is conducted and how images are interpretated based on operator experience. ABUS automates the exam, making it much faster and eliminating the variability in image acquisition.
Using technology to automate the ultrasound imaging process, the somo•v ABUS system was developed specifically for the high-volume, breast cancer screening environment. The somo•VIEWer advanced 3-D workstation enables fast, accurate review and archiving of patient exams, optimizing breast ultrasound screening workflow.
For more information: www.u-systems.com