Reflectance Medical has announced it has received FDA clearance for its CareGuide oximeter, according to a news release (pdf).
The CareGuide oximeter is the initial product for Reflectance Medical, which focuses on the development of physiologic sensors to non-invasively and continuously assess patient metabolic status, according to the company. The oximeter has been approved as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in skeletal muscle tissue.
"FDA clearance is a major milestone for our company and the first step in a potential paradigm shift in monitoring critically and chronically ill patients," said John L. Brooks III, chairman of Reflectance Medical, in the release. "This approval represents the culmination of over a decade of work by our scientific founder Babs Soller and we are thrilled with this result for her and her team."
Reflectance Medical expects to file an FDA 510(k) application for a mobile version of the CareGuide oximeter in the third quarter of 2012.
Reflectance Medical is headquartered in Westborough, Mass.
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