GE has provided the FDA with the device description and non-clinical information, including phantom testing, and detector performance evaluation
WAUKESHA, WI -- NOVEMBER 10, 2011-- GE Healthcare, a unit of General Electric Company (NYSE:GE), announced that it recently submitted to the U.S. Food and Drug Administration (FDA) the first module of its premarket approval application (PMA) for GE Breast Tomosynthesis, an option of the Senographe* Essential system.
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GE Healthcare's 7.0T MRI investigational device will be used to support UI research on functional brain mapping, high resolution anatomical imaging of the brain, spectroscopy of the brain, evaluation of tumor response to treatment, and cardiovascular imaging
Waukesha, WI---November 1, 2011---GE Healthcare and University of Iowa Health Care announced they will collaborate on ultra-high field Magnetic Resonance Imaging (MRI) to study brain disorders.
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PITTSBURGH--(BUSINESS WIRE)--GE announced today the shipment of the Omnyx™ VL4 scanner to beta customers worldwide. To date, six Omnyx VL4 scanners have been shipped and are in operation for testing purposes. This marks a significant milestone in Omnyx's efforts to deliver a leading Integrated Digital Pathology solution. The Omnyx solution will be demonstrated at the upcoming Pathology Visions conference in San Diego
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Europe - October 27, 2011 -- GE Healthcare's latest commitment to improving patient care and the global healthcare delivery system was announced today in Milan, Italy as the Lombardia Ministry of Health (MoH) purchased 135 units of GE Healthcare's pocket-sized, ultrasound medical imaging device Vscan for use by general practitioners in the region. This effort by GE Healthcare and the Lombardia MoH is not only the first of its kind for Italy, but also unique to Europe.