May 28, 2008 - Somanetics Corp. said this week it received FDA 510(k) clearance to expand the labeling for its INVOS Cerebral/Somatic Oximeter System.
The company said the clearance will help its product be more useful in the pediatric and neonatal ICU markets. The 510(k) expands the indication for use to include monitoring tissues beneath the sensor, not limited to brain and skeletal muscle tissue. It also simplifies the indication for use language and clarifies the technology is for use on any individual, described as neonates, infants, children and adults. It also incorporates changes we have made to the newest INVOS Model 5100C monitor.
In the smaller patients found in the neonatal ICU, data shows that placing the sensors over the abdomen and flank provides important information from the bowels and kidney.
Somanetics develops, manufactures and markets the INVOS Cerebral/Somatic Oximeter System, a noninvasive patient monitoring system that continuously measures changes in the blood oxygen levels in the brain and elsewhere in the body in patients with or at risk for restricted blood flow. Surgeons, anesthesiologists, intensive care nurses and other medical professionals can use the information provided by the INVOS System, in conjunction with other available information, to identify oxygen imbalances in tissues beneath the sensor.
For more information: www.somanetics.com