FDA clears Reflectance's muscle oxygen saturation, tissue acidosis sensor

By Brian Dolan
10:55 am

Reflectance 2This month the FDA cleared Westborough, MA−based Reflectance Medical's noninvasive, peel-and-stick sensor for measuring muscle oxygen saturation (SmO2) and pH (pHm), an indicator of tissue acidosis. Reflectance's Multi-Parameter Mobile CareGuide 3100, which simultaneously and continually measures those two parameters, secured Class II clearance. Quickly reversing acidosis can help prevent serious complications like organ failure and death. As a result the company aims to prevent costly ICU stays, too.

Notably, Reflectance spun out of the University of Massachusetts back in 2009.

Reflectance plans to bring its Mobile CareGuide 3100 to market thanks to partners Zoll Medical and Sotera Wireless. Those partnerships will focus on leveraging the monitor to improve care for trauma patients, but Reflectance also aims to ink deals with companies to help congestive heart failure patients, too. The company is also reportedly bringing its wares to the US military.

“For the first time, patient acid-base status can be assessed and monitored without the need for blood draws or invasive catheter," Reflectance President and CEO Babs Soller stated in a press release. "Reflectance has developed an Android app to begin to explore opportunities for CareGuide in clinics and patient homes.”


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