April 18, 2014 9:12 PM ET

Healthcare Equipment and Supplies

Company Overview of U-Systems, Inc.

Company Overview

U-Systems, Inc. develops automated breast ultrasound systems. It offers somo•v INSIGHT Class, an automated breast ultrasound system; and somo•VIEWer Advanced 3D Workstation for diagnostic use as an adjunct to mammography. The company’s products assist radiologists in the early detection of breast lesions. U-Systems, Inc. was founded in 1997 and is headquartered in Sunnyvale, California. As of November 9, 2012, U-Systems, Inc. operates as a subsidiary of GE Healthcare Ltd.

447 Indio Way

Sunnyvale, CA 94085

United States

Founded in 1997

Phone:

408-245-1970

Fax:

408-738-9156

Key Executives for U-Systems, Inc.

Chief Executive Officer
Founder and Director
Chief Financial Officer
Vice President of Engineering
Vice President of Regulatory Affairs and Quality Assurance
Compensation as of Fiscal Year 2013.

U-Systems, Inc. Key Developments

U-Systems, Inc.'s somo--v Automated Breast Ultrasound (ABUS) System Receives FDA Approval for Breast Cancer Screening

U-Systems, Inc. announced that the somo--v(R) Automated Breast Ultrasound (ABUS) system has been approved by the U.S. Food and Drug Administration's (FDA) for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue. With the approval, the somo--v ABUS system becomes the only device approved specifically for screening women with dense breasts. FDA approval comes after a Radiological Devices Panel of the FDA's Medical Devices Advisory Committee unanimously recommended approval of U-Systems' premarket approval (PMA) application in April. The somo--v ABUS system is the only ultrasound device approved for breast cancer screening in the United States, Canada and 27 European Union countries as an adjunct to mammography for asymptomatic women with dense breast tissue. Dense breast tissue not only increases the risk of breast cancer up to 4-6 times but also makes cancer more difficult to detect using mammography, according to multiple large studies. Using proprietary technology to automate the ultrasound imaging process, the U-Systems' somo--v ABUS system was developed specifically for the high-volume, breast cancer screening environment. The somo--VIEWer(TM) Advanced 3D Workstation enables fast, accurate review and archiving of patient exams, optimizing breast ultrasound screening workflow.

U-Systems, Inc. Receives FDA PMA Approvable Letter for Somo--V Automated Breast Ultrasound (ABUS) System

U-Systems, Inc. announced it has received a PMA approvable letter from the U.S. Food and Drug Administration's for the company's somo--v(R) Automated Breast Ultrasound (ABUS) system. The somo--v ABUS system is the first ultrasound device to receive an approval recommendation from a FDA Advisory Panel and an approvable letter for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue. Dense breast tissue not only increases the risk of breast cancer up to 4-6 times but also makes cancer more difficult to detect via mammography according to multiple large studies. One study, published in the New England Journal of Medicine, showed 35% of breast cancer goes undetected by mammography in women with dense breasts, as density masks appearance of tumors (Boyd, et al, NEJM 2007:356:227-36M). As breast density goes up, the accuracy of the mammogram goes down. Using proprietary technology to automate the ultrasound imaging process, the U-Systems' somo--v ABUS system was developed specifically for the high-volume, breast cancer screening environment. The somo--VIEWer(TM) Advanced 3D Workstation enables fast, accurate review and archive of patient exams, optimizing breast ultrasound screening workflow. Final approval of the company's pre-market approval (PMA) application for the system remains subject to satisfactory review and inspection of U-Systems manufacturing facilities, methods and controls. The company plans to work closely with the FDA to complete this final inspection.

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