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FDA clears Reflectance CareGuide Oximeter

The US Food and Drug Administration (FDA) has granted 510(k) approval to Reflectance Medical's CareGuide Oximeter.

CareGuide Oximeter monitors hemoglobin oxygen saturation of microvascular blood in skeletal muscle tissue (muscle oxygen saturation or SmO2) and assess tissue perfusion on patients with pigmented skin.

CareGuide also provides caregivers with critical information that whether oxygen is being delivered to meet the muscle’s metabolic demand or not.

The company is expecting to file a 510(k) application for a mobile version of the CareGuide Oximeter in the third quarter of 2012, and a 510(k) application for a next-generation version of CareGuide to assess muscle pH and hematocrit simultaneously with SmO2 before the end of 2012.

Reflectance Medical founder president and chief executive officer Babs Soller said the company looks forward to future dialogue with FDA regarding its next-generation devices.

"We believe our innovative patient-monitoring platform has the potential to noninvasively and continuously deliver healthcare providers with real-time, critical, patient care information to help physicians identify and reverse conditions associated with low muscle pH," Soller added.