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Updates already have stamp of approval from FDA and EU.
IMRIS Inc. has earned Health Canada licensing to incorporate next generation MRI (magnetic resonance imaging) core technology into its Visius Surgical Theater for sales and marketing in the country. This newest imaging technology, based on the Siemens Aera 1.5T (Tesla) and Skyra 3.0T MRI scanners, helps IMRIS deliver even better image quality, faster 3-D image acquisition, and improved ease-of-use and workflow during surgical procedures using intraoperative MRI (iMRI). The company received United States Food and Drug Administration clearance for these advancements in February 2014 and in July received CE mark authorization in Europe. “Hospitals who adopt this technology in our Visius solution will have access to the highest quality MR applications and images within the operating room setting,” said President and CEO Jay D. Miller. “This latest and unequaled imaging technology in the hands of neurosurgeons is improving patient outcomes and making newer minimally-invasive treatment options for brain tumors, epilepsy and other therapies work better.” Inside a Visius Surgical Theater equipped with high-field iMRI, surgeons have on-demand access to real-time data and state-of-the-art imaging during the procedure as the scanner uniquely moves on ceiling-mounted rails. The company also designs and manufactures proprietary intraoperative CTs (computed tomography scans), head fixation devices, imaging coils, and operating room tables for use in this unique and multifunctional intraoperative environment. The Visius Surgical Theater is a surgical environment designed to provide intraoperative vision to clinicians to assist in decision making and enhance precision in treatment. The multi-room suites incorporate diagnostic quality high-field MR, CT and angio modalities accessed in the operating room setting. Visius Surgical Theaters serve the neurosurgical, spinal, cardiovascular and cerebrovascular markets.
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