[01/13/2005] ViOptix, a Fremont, CA-based developer and manufacturer of non-invasive local tissue oxygen measuring devices, announced today that its product: the ODISsey™ Tissue Oximeter has received market clearance from the US Food and Drug Administration (FDA). Market introduction of the ODISsey™ will take place immediately.
Mohamed Elmandjra, ViOptix President and CEO, stated, "We are very pleased to receive FDA 510(k) clearance on our first product. This is a key achievement for us and for non-invasive tissue oxygen assessment in general. We are committed to bringing innovative products with high clinical value to the healthcare market, and FDA clearance is definitely a major milestone toward that goal.”
About ViOptix, Inc.
Backed by venture capital, ViOptix, Inc. (www.vioptix.com) has developed and patented a revolutionary new technology (Optical Diffusion Imaging and Spectroscopy or “ODIS”), that enables non-invasive, direct, real-time estimation of local tissue oxygen saturation (StO2) on a very cost-effective basis. Its technology will be used in diagnostic and monitoring equipment that has a wide variety of potential clinical applications.
ViOptix is located in Fremont, California, in the Silicon Valley area. Its private Canadian venture company, ViOptix Canada, is headquartered in Toronto, Ontario, Canada.
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