ThromboVision Inc


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ThromboVision Inc. has filed a 510(k) application with the Food and Drug Administration for clearance to market the T-Guide. Clinical trial data were gathered through independent studies at four research facilities, The Methodist Hospital Research Institute, Houston, University of Arizona, Tucson, Intermountain Medical Center, Salt Lake City, and Houston Institute for Clinical Research. The principal investigators at the sites were Drs. Neal Kleiman, Marvin Slepian, Jeffrey Anderson, and Dale Halter, respectively. A successful 510(k) application results in FDA clearance to market the device. The T-Guide(R) consists of a disposable test kit and a point-of-care base unit. The system will help physicians improve their cardiac patients' lives by providing additional information as they assess an individual patient's anti-platelet therapy used to prevent heart attacks, strokes and stent occlusions.