Medical Devices

FDA clearance of Habib4x announced, LifeGuard Vision safety needle introduced

Published in Cancer Weekly, September 13th, 2005

RITA Medical Systems, Inc., (RITA) announced that the Habib4x Resection device received clearance from the U.S. Food and Drug Administration (FDA) and that the company will begin U.S. commercialization of the product for use in vascular tissue coagulation during surgical resection.

The Habib4x Resection device is also labeled with the CE Mark for distribution in Europe and is currently marketed by the company's international distribution network. Given the timing of the approval from the FDA and the requirements of a product launch in the U.S., the company expects to begin shipping the product in mid-September 2005. In Europe, the company has seen positive interest in...

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Source: Cancer Weekly (2005-09-13)

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