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U-Systems, Inc. and Dr. Marc Inciardi of The University of Kansas Hospital Announces Initiation of the SOMO·INSIGHT Clinical Study
| Company News - U-Systems, Inc. |
U-Systems and Marc F. Inciardi of The University of Kansas Breast Imaging Center announced that they have initiated the SOMO·INSIGHT Clinical Study
U-Systems, the leader in dedicated breast ultrasound systems, and Marc F. Inciardi, MD, Radiologist, The University of Kansas Breast Imaging Center, announced that they have initiated the SOMO·INSIGHT Clinical Study and the first participants have been enrolled. The clinical study is examining whether Digital Mammography along with the somo•v Automated Breast Ultrasound (ABUS) is more sensitive to detecting breast lesions when compared to Mammography alone in women with dense breasts.
The initiation of this nationwide study, which intends to recruit over 20,000 women, is an important milestone for U-Systems in evaluating new approaches to improve cancer detection. Screening mammography can be limited in women with dense breasts and these women have a higher risk of breast cancer. ABUS uses ultrasound (sound waves) at a safe frequency to create images of the breast tissue, unlike mammography, which uses radiation. Ultrasound has been shown to find cancer not visible with mammography in women who have dense breasts. It is for this reason that U-Systems developed the somo•v and is sponsoring the SOMO·INSIGHT clinical study.
Dr. Marc F. Inciardi, Principal Investigator for the SOMO·INSIGHT Clinical Study stated, “The start of the SOMO·INSIGHT Clinical Study at the Breast Center is an important step forward in instituting new screening approaches for earlier detection of breast cancer. This research study allows us to bring cutting edge technology to our patients in the community and potentially detect cancers earlier in the fight against breast cancer. The University of Kansas Breast Imaging Center is the only facility to participate in this study in Kansas and Missouri.”
Ron Ho, President and CEO of U-Systems said, “We are very excited to be initiating the SOMO·INSIGHT Clinical Study with Dr. Inciardi of The University of Kansas Hospital. We believe that somo•v ABUS technology will play a vital role in significantly advancing breast cancer screening. The use of the somo•v ABUS in combination with mammography may aid the physician in earlier detection of breast cancer for this large group of asymptomatic women with increased 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 University of Kansas Hospital
The University of Kansas Hospital and the Richard and Annette Bloch Cancer Care Pavilion are transforming cancer research and clinical care by linking our innovative approach to drug discovery, delivery, and development to our nationally-accredited patient care program. Our partnership includes cancer research and healthcare professionals associated with the University of Kansas Medical Center and The University of Kansas Hospital in Kansas City, the University of Kansas in Lawrence, the University of Kansas School of Medicine in Wichita, and the members of the Midwest Cancer Alliance Partners Advisory Board and Clinical Trials Network. For more information on The University of Kansas Cancer Center’s research and outreach programs and award-winning patient care offered at the Richard and Annette Bloch Cancer Care Pavilion and The University of Kansas Hospital, visit http://cancer.kansas.edu
Source: U-Systems











