Biosense Webster

U.S. FDA grants market clearance for diagnosis and treatment system for abnormal heart rhythms

Published in Medical Verdicts and Law Weekly, July 27th, 2006

The U.S. Food & Drug Administration (FDA) has cleared for marketing under a 510K application a technology designed to help in the diagnose and planning of treatment for patients with abnormal heart rhythms.

The Carto RMT V8 System from Biosense Webster, Inc. and the Niobe Magnetic Navigation System from Stereotaxis, Inc. provide electrophysiologists (doctors specializing in the heart's electrical system) with automated 3D mapping and navigation tools, and a magnetic steering platform.

Among system integration has real-time feedback in guiding the catheter to the target and simultaneous display of the NaviStar RMT catheter on Carto RMT System and...

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Source: Medical Verdicts and Law Weekly (2006-07-27)

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