GE's Compact Ultrasound Cleared by FDA
May 11, 2006
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GE Healthcare, a unit of General Electric Company, announced it received U.S. Food and Drug Administration (FDA) clearance for its Voluson i, the world's first and only 4-D compact ultrasound system designed specifically for women's healthcare, including obstetric, gynecological and other clinical applications.

This new compact system allows clinicians to make real-time diagnoses, particularly for high-risk patients, by providing high-quality 4-D imaging to wherever the patient is located.

The ultrasound system will help enhance the efficiency and reach of clinicians by offering the functionality and high performance of a console-size ultrasound system in a portable design that weighs slightly more than the average newborn. This benefit, coupled with the system's ease-of-use, enables facilities of all sizes to offer 4-D imaging as the standard of care for prenatal women. The portability of the Voluson i also makes it ideal for community and rural clinics, as well as mobile imaging services.

"The Voluson i will support a completely new level of efficiency for OB/GYN physicians, enabling them to deliver patient care anywhere it's needed," said Omar Ishrak, president and CEO of GE Healthcare's Clinical Systems business.

According to Ishrak, there is a need for more specialized, high-quality point of care systems to meet the growing demands for diagnosis on the spot. "Voluson i addresses one of the biggest challenges OB/GYN physicians face in caring for their high-risk patients--access to complete, real-time information that allows them to make clinical decisions at the patient's bedside with confidence," he said.

The Voluson i is FDA-cleared and is now commercially available in the U.S.

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