01.12.2014 12:21:32
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IMRIS Completes SYMBIS Surgical System Human Factors Study
(RTTNews) - IMRIS Inc. (IMRS, IM.TO) has completed the human factors study for the SYMBIS Surgical System, the comprehensive validation used to support the product's 510(k) submission to the U.S. Food and Drug Administration or FDA on November 26.
The SYMBIS human factors trial involved a diverse group of 18 neurosurgeons of varying demographics and range of neurosurgical experience. Subjects were recruited from 9 leading neurosurgical centers in the U.S., including three centers that do not currently have a VISIUS Surgical Theatre with intraoperative MRI or iMRI.
Human factors is the science of understanding how humans interact physically and psychologically with a device.
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