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.
Currently, acidosis is assessed with repeated blood sampling and laboratory analysis to determine pH. Mobile CareGuide 3100 is expected to reduce serial blood sampling and provide clinicians with real-time pHm measurements, to help promptly reverse acidosis, thereby avoiding complications that could result in costly ICU stays.
Reflectance Medical is bringing the Mobile CareGuide 3100 to market in partnership with ZOLL Medical and Sotera Wireless, focusing initially on improving care for trauma and other critically ill patients. Reflectance is seeking additional strategic partners to help bring this innovative noninvasive sensing platform to new markets, including monitoring of patients with chronic conditions such as congestive heart failure.