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January 7, 2014
06:32 EDTSTXSStereotaxis completes clinical trial of Vdrive with V-Loop required by the FDA
Stereotaxis announced that it has completed the clinical trial required for FDA clearance of the Company's Vdrive Robotic Navigation System with V-Loop Circular Catheter Manipulator. Results of the 120-patient study, which was conducted at three Stereotaxis sites in the U.S. and two in Europe, will be included in a 510 Premarket Notification the Company intends to submit in the Q1. If cleared by the FDA, the Vdrive with V-Loop system will be the Company's second Vdrive product to be cleared for use in the U.S. Its Vdrive with V-Sono Intracardiac Echocardiography Catheter Manipulator received FDA clearance in July 2013 and has been utilized in more than 50 cardiac ablation procedures to date in the U.S.
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November 17, 2015
09:08 EDTSTXSStereotaxis: multicenter study shows long-term success rates with Niobe in VT
Stereotaxis announced the results of an independent multicenter study on the procedural benefits and outcomes of patients undergoing radiofrequency ablation therapy for ventricular tachycardia, or VT, using the Niobe remote magnetic navigation system compared to manual catheter approaches. The study findings, which were recently published at the American Heart Association Scientific Sessions, represent the most significant long-term outcomes to date with the Niobe system in VT and were considerably better than those in the manual catheter group.

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