TROY, MI /PRNewswire-FirstCall/ -- Somanetics Corp. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the labeling for its INVOS Cerebral/Somatic Oximeter System.
"We believe this new 510(k) will serve to support our ongoing efforts in the pediatric and neonatal ICU market segments in several ways," said Bruce Barrett, Somanetics' President and CEO. "First, the 510(k) expands the indication for use to include monitoring tissue beneath the sensor, not limited to brain and skeletal muscle tissue. Second, it simplifies the indication for use language and clarifies that 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 addition, the 510(k) includes results from the company's neonatal piglet trials," said Barrett. "In the smaller patients found in the neonatal ICU, in particular, the neonatal piglet data shows that placing the sensors over the abdomen and flank provides important information from the bowels and kidney, respectively. We can now discuss these applications with our customers in a meaningful way," he said.
Somanetics Corp. 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 with other available information to identify oxygen imbalances in tissue beneath the sensor and take necessary corrective action, potentially improving patient outcomes and reducing the costs of care. Somanetics supports its customers through a direct U.S. sales force and clinical education team. Covidien markets INVOS System products in Europe, Canada, the Middle East, and South Africa and Edwards Lifesciences represents INVOS System products in Japan.