Somanetics Submits 510(k) to Expand INVOS Technology Labeling

Somanetics announced that it has submitted a 510(k) premarket notification to the FDA to apply for clearance to market the INVOS technology to monitor changes in blood oxygen saturation in regions of the body other than the brain. This new application of the INVOS technology, which will include a new disposable SomaSensor, is intended as an adjunct monitor of hemoglobin oxygen saturation of blood in tissue beneath the sensor in infants, children and adults at risk of reduced-flow or no-flow ischemic states in critical care settings.

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