Capnometry Sensor Cleared by FDA

A disposable probe designed to measure sublingual CO2 for patient monitoring in cases of tissue hypoperfusion secondary to hypovolemic, cardiogenic, or septic shock has been cleared by the U.S. Food and Drug Administration (FDA).

The sensor, called CapnoProbe, is the product of Optical Sensors Inc. (OSI, Minneapolis, MN, USA), a technology development company specializing in low-cost fiberoptic sensors and instruments. The CapnoProbe is based on patents licensed to OSI by the Institute of Critical Care Medicine (ICCM, Palm Springs, CA, USA). ICCM says it developed the initial concept of measuring carbon dioxide tension under the tongue using a sensor similar to an oral thermometer in order to assess sublingual and esophageal pCO2 measurement as an aid in the diagnosis and monitoring of patient status.

"This approval allows OSI to proceed with its plans to pursue a major health care products distribution partner for the CapnoProbe sensor and complete CapnoProbe's commercial configuration for sale into the hospital medical marketplace,” said Paulita LaPlante, president and CEO of OSI.



Related Links:
OSI