Reflectance Medical Receives FDA Clearance for Mobile Careguide™ 3100 With The First-ever Noninvasive pH Sensor
Reflectance Medical, a developer of innovative noninvasive medical sensors, announced today that it received 510(k) clearance for the battery-powered Multi-Parameter Mobile CareGuide™ 3100 which simultaneously and continually measures muscle oxygen saturation (SmO2) and pH (pHm). Reflectance Medical is the only company to offer technology that noninvasively measures pHm, an indicator of tissue acidosis. Numerous medical conditions are marked by tissue acidosis, a result of inadequate oxygen delivery and a buildup of lactic acid. Prompt reversal of acidosis helps avoid serious complications, which can include organ failure and death. 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.
"Reflectance Medical is poised to take advantage of the explosive interest in remote patient monitoring and mobile health applications" says Reflectance President and CEO, Babs Soller. "For the first time, patient acid-base status can be assessed and monitored without the need for blood draws or invasive catheters. Reflectance has developed an Android app to begin to explore opportunities for CareGuide in clinics and patient homes."