CHICAGO, Nov. 28, 2011 /PRNewswire/ -- U-Systems, the leader in automated breast ultrasound, today announced the introduction of the somo-v Platinum, a significant update to the somo-v® Automated Breast Ultrasound (ABUS) system. The somo-v ABUS is first and only ultrasound system designed specifically for high-volume breast screening. Featuring proprietary imaging performance and screening workflow advances, the somo-v ABUS Platinum has been specifically designed to streamline exam efficiency while improving image quality and clinical confidence. The company made the announcement here at the 97th Annual Meeting of the Radiology Society of North America, November 27 – December 2.
U-Systems also recently announced that the U.S. Food & Drug Administration (FDA) accepted its premarket approval (PMA) application for review. The PMA is seeking a breast cancer screening indication for the somo-v® Automated Breast Ultrasound (ABUS) system, which is currently FDA-cleared for diagnostic use as an adjunct to mammography.
Imaging Performance and Patient Comfort
The Platinum system features U-Systems' revolutionary new class of transducer technology designed to deliver unparalleled imaging performance and patient comfort. The ergonomic Reverse Curve Technology conforms to anatomic curve of women's breasts for improved comfort and imaging performance during an automated 3D ultrasound exam. The Reverse Curve Technology uses convergent scan line geometry, enabling ultrasound beams, or sound waves, to penetrate the skin perpendicularly, improving penetration and sharpening focus at depth. Additionally, the Reverse Curve Technology creates uniform compression thickness across the entire breast enhancing image equality. Greater image overlap ensures wide field-of-view imaging, increasing confidence of viewing entire breast.
Reverse Curve Technology also incorporates the Soft Touch Floating Compression Membrane. Designed specifically for use with the somo-v ABUS System, the Soft Touch Membrane provides the highest exam quality with a greater level of patient comfort. The Soft Touch Membrane was developed to instantly adapt to woman's unique anatomy and evenly distribute pressure across the breast for a quick, comfortable exam. The anatomic shape will also expedite patient positioning for improved workflow.
Dedicated Breast Screening Workflow
Based on more than 16,000 ABUS studies, Abella™ Workflow is a proprietary clinical workflow method for the quick, accurate review of automated breast ultrasound exams. Designed specifically for high-throughput breast screening environment, Abella presents optimized ABUS 3D breast image volumes quickly, and in precise hanging protocols aimed at improving exam efficiency and clinical confidence.
Abella Workflow applies advanced image processing algorithms which reduce background noise, improve contrast and sharpen detail resolution. Combined with the imaging performance enhancements and expedited patient positioning from the new Reverse Curve Technology, Abella not only ensures the best image quality, but also improves review time for maximum throughput and productivity.
Abella also features enhanced viewing protocols validated by some of the nation's leading breast imaging experts. Abella viewing protocols offer the industry's most advanced approach to reviewing Automated Breast Ultrasound exams. Initial clinical experience with Abella workflow demonstrates that trained clinicians can consistently and accurately review ABUS exams in three minutes or less with a high degree of clinical confidence.
"The somo-v® Platinum and Abella™ Workflow represent a significant step forward for the somo-v ABUS system, which is the first and only Automated Breast Ultrasound System designed from the ground up specifically for breast screening," said Ron Ho, U-Systems president and CEO. "Featuring breakthrough new image acquisition and workflow technologies developed from our extensive clinical experience with more than 16,000 ABUS exams, the ABUS system now has a level of efficiency and clinical confidence never before seen in Automated Breast Ultrasound. All this and a refreshing new look too."
Proven Clinical Performance
The somo-v ABUS incorporates the latest, state-of-the-industry automated ultrasound technology delivering uncompromised image quality, streamlining clinical workflow, and providing unprecedented clinical confidence. FDA cleared for diagnostic use, the somo-v ABUS was developed as the foundation technology for U-Systems' ground-breaking, prospective SOMO-INSIGHT Clinical Study, the largest clinical study ever conducted by an ultrasound company. The Study is designed to evaluate whether ABUS, in combination with digital mammography is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with dense breast tissue.
As the leader in automated breast ultrasound technology U-Systems is establishing the standard for breast ultrasound screening. The U-Systems' somo-v Automated Breast Ultrasound (ABUS) system and somo-VIEWer Advanced 3D Workstation are cleared under 510(k) for diagnostic use as an adjunct to mammography. For more information about U-Systems, please visit booth 9100 at RSNA and visit or website at http://www.u-systems.com.
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