Health Canada Approves U-Systems somo•v™ Automated Breast
Ultrasound (ABUS) for Breast Cancer Screening
Vancouver, Toronto GTA, Montreal, Ottawa, Halifax. (PRWEB) October 09, 2011
VIP Breast Imaging announces its first installation of somo•v™ Automated Breast Ultrasound (ABUS) at their flagship imaging in Toronto. VIP Breast Imaging offers diagnosis and screening for breast cancer using the latest state-of-the-art advanced 3D ultrasound system. VIP Breast Imaging offers safe, radiation-free and gentle breast screening in a comfortable, client-friendly, outpatient environment. The company is committed to expanding access to ABUS cancer screening from coast-to-coast across Canada.
“We are very excited to offer somo•v™ Automated Breast Ultrasound (ABUS) as an adjunct to mammography in the early detection of breast cancer for Canadian women and their families. The ABUS system has been proven effective in women with dense breast tissue which not only impacts detection but also carries an increased risk of breast cancer,” said Tina Ureten, MD, RDMS, RDCS, founder and president of VIP Breast Imaging. “We are proud to offer safe, radiation-free and gentle breast screening that will benefit all Canadian women, regardless of age or family history. ABUS can be used safely for younger, pregnant, lactating, post-operative or women who are high risk and would otherwise be adverse to receiving a radiation dose from a mammogram.”
The company also announced today, the Medical Devices Bureau of Health Canada has granted U-Systems, the leader in automated breast ultrasound, a medical device license by to sell and market the somo•v™ Automated Breast Ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in Canada.
The somo•v ABUS system is the only ultrasound device approved for breast cancer screening by Health Canada, the agency responsible for assessing medical device safety, effectiveness and quality in Canada. The somo•v ABUS system is also the only ultrasound device approved for breast cancer screening in the 27 European Union countries. In the U.S. the somo•v ABUS system is cleared by the Food & Drug Administration (FDA) for adjunctive diagnostic use with mammography.
Approval for somo•v™ Automated Breast Ultrasound (ABUS) system was based on extensive clinical evidence and includes the following indication: “The somo•v ABUS ultrasound device is intended for use as an adjunct to mammography to provide physicians with an increase in the sensitivity of breast cancer detection in diagnostic symptomatic and screening asymptomatic women.”
“With this approval from Health Canada, we are proud to make this critical screening tool available to Canadian women to improve the early detection of breast cancer, particularly in women with dense breasts,” said Ward Sullivan, CEO of VIP Breast Imaging. “ABUS is not intended as a replacement for mammography; however, there is strong scientific evidence that for women with dense breast tissue, supplementing mammograms with ABUS can substantially increase breast cancer detection.”
A growing body of research demonstrates a strong link between breast density and increased cancer risk; up to 4-6 times in one study (Boyd, et al. New England Journal of Medicine 2007; 356:227-36M). The 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. Since both dense breast tissue and cancer appear white on a mammogram, it is difficult to detect cancer when there is increased dense breast tissue. As breast density increases, the accuracy of the mammogram decreases.
Comfortable breast screening is possible. Comfortable breast screening is here.
About VIP Breast Imaging
VIP Breast Imaging is dedicated to providing safe, accessible, cost-effective screening in the early detection of breast cancer for Canadian women and their families. Our mission is to provide a life saving opportunity to all who seek out our service, and to do this by offering the latest state-of-the-art advanced ultrasound systems for safe and accurate breast scanning, operated by caring, professionally trained, and licensed staff, in a comfortable, relaxing environment. For more information, please visit: http://www.vipbreastimaging.com
U-Systems is the leader in Automated Breast Ultrasound and the sponsor of the SOMO•INSIGHT, a 20,000 women, multi-center, prospective clinical study designed to determine the cancer detection sensitivity of somo•v Automated Breast Ultrasound (ABUS), combined with mammography, compared to mammography alone for women with dense breast tissue. To date, the study has identified a significant number of mammographically negative breast cancers subsequently detected by ABUS. The U-Systems somo•v ABUS system is currently cleared under 510(k), as an adjunct to mammography. The somo•v ABUS system is not intended to replace screening mammography. For more information, please visit: http://www.u-systems.com.