National SOMO•INSIGHT Clinical Study Investigating Ultrasound Screening with Mammography for Women with Dense Breasts
DETROIT & SUNNYVALE, Calif.--(BUSINESS WIRE)-- Henry Ford West Bloomfield Hospital announced today that it has joined U-Systems national clinical research study designed to evaluate whether digital mammography, when combined with the somo•v™ Automated Breast Ultrasound System (ABUS) from U-Systems, Inc (Sunnyvale, CA), is more sensitive in detecting breast lesions compared to mammography alone in women with dense breasts. Henry Ford West Bloomfield Hospital is the only site in Michigan, and one of only ten breast cancer centers in the entire country, currently recruiting women for the SOMO•INSIGHT clinical study.
“While mammography remains the gold standard, visualization of cancers in dense breast tissue with mammography can be limited in some women,” says Henry Ford radiologist Biren A. Shah, M.D., who is principal investigator for the SOMO•INSIGHT Clinical Study at Henry Ford West Bloomfield Hospital. “It is exciting to participate in this study designed to determine if somo•v Automated Breast Ultrasound can identify breast cancers not seen with digital mammography alone, in women with dense breasts. We believe if this study is successful, it will be a tremendous technological advancement in early breast cancer detection, especially for the high risk group of women with dense breasts.”
The SOMO•INSIGHT multi-center study will enroll up to 20,000 women at clinical study sites in the United States to determine the sensitivity of mammography and somo•v together, compared to mammography alone for women with greater than fifty percent dense breast tissue.
Ron Ho, President and CEO of U-Systems said, “We are honored to partner with Dr. Shah and Henry Ford West Bloomfield Hospital for the SOMO•INSIGHT Clinical Study as we believe that somo•v ABUS technology will play a vital role in significantly advancing breast cancer screening.”
Unlike mammography, which uses radiation to identify breast cancer lesions, somo•v ABUS technology uses sound waves at a safe frequency to create images of the breast tissue. Ultrasound has been shown to find cancer that may not be visible with mammography alone, in women who have dense breasts.
About Henry Ford West Bloomfield Hospital
Henry Ford West Bloomfield Hospital, part of the Henry Ford Health System, offers full-service medical and surgical services, integrated with wellness and prevention programs. The all-private-room hospital opened with 191 beds, with an additional 109 beds expected to open in 2011. Services include specialty care, 24-hour emergency care, a senior neuroscience center, a wellness center with alternative therapies, a unique food culture, and retail shops. The hospital is located on 160 wooded acres, and designed with many energy-efficient and environmentally friendly features. To learn more, visit www.henryfordwestbloomfield.com.
About the SOMO•INSIGHT Clinical Study
Sponsored by U-Systems, located in Sunnyvale, CA, the SOMO•INSIGHT Clinical Study is a multi-center breast cancer screening study using somo•v Automated Breast Ultrasound System (ABUS). The purpose of the SOMO•INSIGHT Clinical Study is to evaluate the sensitivity of Mammography and somo•v together, as compared to Mammography alone, as a breast cancer screening method in women with greater than fifty percent breast tissue density. More information on the SOMO•INSIGHT Study is available at http://www.somoinsightstudy.org.
About U-Systems, Inc
U-Systems is the leader in automated breast ultrasound technology. For more information, please visit our website at http://www.u-systems.com. The somo•v ABUS is currently cleared under 510(k). The device is indicated for use as an adjunct to mammography for diagnostic ultrasound breast imaging. The device is not intended to be used as a replacement for screening mammography.
CONTACT:
For Henry Ford Hospital
Krista Hopson, 313-874-7207
[email protected]
or
For U-Systems, Inc
Chris K. Joseph, 510-435-4031
[email protected]
KEYWORDS: United States North America California Michigan
INDUSTRY KEYWORDS: Women Technology Other Technology Health Biotechnology Clinical Trials Hospitals Medical Devices Oncology Radiology Research Consumer Science
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