Westborough, Mass.-based Reflectance Medical became the first company to receive FDA 510(k) clearance for an oximeter and tissue perfusion system designed for patients with pigmented skin.
The company’s CareGuide oximeter continuously monitors muscle oxygen saturation (SmO2) and simultaneously assesses tissue perfusion in patients with darker skin tones.
"FDA clearance is a major milestone for our company and the 1st step in a potential paradigm shift in monitoring critically and chronically ill patients," said chairman John Brooks III in prepared remarks. "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."
The device operates by using near infrared rays and non-invasive sensors to collect various medical parameters from the body, using algorithms to translate the data into useful information for healthcare practitioners. The device goes beyond measuring the oxygen carrying capacity of blood and delivers information on oxygen levels in the muscle as well, according to the press release.
The company plans to file a 501(k) application before the end of the year for a mobile version of this oximeter as well as another application for a next-generation device that will monitor muscle pH and hematocrit as well as SmO2.