Somanetics receives 510(k) for INVOS technology:
This article was originally published in Clinica
Executive Summary
US company Somanetics has received a 510(k) clearance from the FDA to market its next generation Cerebral Oximeter. The new patient monitoring system offers technological advances over the current model such as its ability to monitor blood oxygen levels on both sides of the brain simultaneously using two disposable, single-use SomaSensors. It also has automatic calibration and respond faster to physiologic changes.