Medical Devices

U.S. FDA gives market clearance for noninvasive tissue oxygen measuring device

Published in Medical Letter on the CDC and FDA, February 20th, 2005

ViOptix, a Fremont, California-based developer and manufacturer of noninvasive local tissue oxygen measuring devices, announced that its product, the ODISsey Tissue Oximeter has received market clearance from the U.S. Food and Drug Administration (FDA).

Market introduction of the ODISsey will take place immediately.

Mohamed Elmandjra, ViOptix president and CEO, said, "We are very pleased to receive FDA 510(k) clearance on our first product. This is a key achievement for us and for noninvasive tissue oxygen assessment in general."

Backed by venture capital, ViOptix, Inc. has developed and patented a new technology (Optical...

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Source: Medical Letter on the CDC and FDA (2005-02-20)

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