Monday, July 29, 2013
Non-Invasive Muscle Oxygen Saturation and pH Monitor
Anesthesiology / Cardiology / Critical Care / Sports Medicine Reflectance Medical’s FDA Cleared by Editors on Jul 22, 2013 The FDA has issued 510(k) clearance to Reflectance Medical (Westborough, MA) for its Multi-Parameter Mobile CareGuide 3100, a non-invasive device that provides real-time measurement of hemoglobin oxygen saturation (SmO2) and pH (pHm) within muscle below the sensor. Reflectance is the only company offering non-invasive pHm monitoring, which can be used to screen for signs of lactic acidosis, a condition often caused by cell hypoxia and accompanied by increased levels of lactic acid. Simultaneous monitoring of both oxygen and pH levels, which is done automatically every 30 seconds with the CareGuide 3100, should provide an easier approach to diagnosing and monitoring this condition. The device does not need to be calibrated for individual patients and works with skin of any pigmentation.