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Frost & Sullivan Lauds U-Systems for Its Unique Technology and Strategic Excellence Paving the Way for Robust Growth
Date:8/28/2012

ape that enables a quicker, more comfortable breast exam, while improving imaging resolution and reducing artifacts. The system enables rapid review and archiving of patient exams, which optimizes the workflow of the screening process and allows the operator to select individual diagnostic planes, including a high-resolution coronal view, a feature that cannot be achieved on 2D ultrasound.

"By overcoming the ultrasound modality's limitations as an adjunctive to mammography, U-Systems has developed a technology that has the potential to emerge as a life-saving diagnostic aid that enables physicians to effectively diagnose the breast cancers missed by mammography," noted Aranibar. "Even given the recent controversies surrounding breast density and cancer risk, the company's commitment to investing in clinical research aimed at delivering this important breast cancer screening tool can not be understated."

For instance, the company completed a multi-center breast cancer screening clinical study to provide the evidence needed to support a new pre-market application (PMA) submission to the U.S. Food & Drug Administration (FDA) for use of the system in screening applications for women with dense breast tissue. A unanimous vote by the FDA's radiological devices panel recommended approval in April, paving the way for U-Systems' ABUS device to become the first and only ultrasound system to obtain FDA approval for breast cancer screening indications.

U-Systems' path to success can also be attributed to its efforts to raise awareness of healthcare professionals and patients to the issues surrounding breast density. The company's dedication and efforts have attracted more than $30 million in additional venture funding since 2007, which has enabled it to further expand investments in research and development. The company has continued to provide its customers with innovative technology upgrades and enhancements for the somo-v system.

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