SAN JOSE, Calif. & WASHINGTON–(BUSINESS WIRE)–U-Systems, the leader in dedicated breast ultrasound systems, and Rachel F. Brem, MD, professor of Radiology, Director, Breast Imaging and Interventional Center, The George Washington University Medical Faculty Associates, announced that they have initiated the SOMO·INSIGHT Clinical Study and the first participants have been enrolled. The clinical study is examining whether Full Field Digital Mammography along with the somo•v™ Automated Breast Ultrasound (ABUS) can improve breast cancer detection when compared to Mammography alone in women with dense breasts.
Screening mammography, the mainstay for breast cancer detection, can be limited in women with dense breasts and these women have a higher risk of breast cancer. A new approach to improving breast cancer detection is critical for women who undergo mammography with some breast density. It is for this reason that U-Systems developed the somo•v and is sponsoring the clinical study. The initiation of this study, which intends to recruit over 20,000 women, is an extremely important and exciting milestone in evaluating new approaches to improved cancer detection.
Dr. Rachel Brem, Principal Investigator for the SOMO·INSIGHT Clinical Study stated, “The initiation of the SOMO·INSIGHT Clinical Study is an important step forward in instituting new approaches for the improved early detection of breast cancer. This is especially exciting as the somo•v Automated Breast Ultrasound (ABUS) is a quick test that uses NO radiation and has the potential to significantly improve breast cancer detection. This study allows us to bring cutting edge technology to our patients. It is an honor to be leading this study.”
Ron Ho, President and CEO of U-Systems said, “We are pleased to be initiating the SOMO·INSIGHT Clinical Study with Dr. Brem of The George Washington University Medical Faculty Associates. This is a major milestone for U-Systems, and through our partnerships with our clinical sites, we believe this will be a remarkable step towards new advancements in breast cancer screening. The use of the somo•v™ ABUS in combination with mammography will aid the physician in earlier detection of breast cancer for this large group of asymptomatic women with breast density.”
About U-Systems
U-Systems is the leader in developing dedicated breast ultrasound systems. For more information, please visit our website at http://www.u-systems.com. The U-Systems somo•v Automated Breast Ultrasound System (ABUS) is currently cleared under 510(k). The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient’s breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.
About the George Washington University Medical Center
The George Washington University Medical Center is an internationally recognized interdisciplinary academic health center that has consistently provided high-quality medical care in the Washington, DC metropolitan area, since 1824. The Medical Center comprises the School of Medicine and Health Sciences, the 11th oldest medical school in the country; the School of Public Health and Health Services, the only such school in the nation’s capital; GW Hospital, jointly owned and operated by a partnership between The George Washington University and a subsidiary of Universal Health Services, Inc.; and the GW Medical Faculty Associates, an independent faculty practice plan. For more information on GWUMC, visit www.gwumc.edu.
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Contacts
U-Systems
May Calceta, 408-750-1317
mcalceta@u-systems.com
or
George Washington University Medical Faculty Associates
Anne Banner, 202-994-2261
mcmacb@gwumc.edu
