Somanetics Receives FDA Clearance From For INVOS System Labeling
Somanetics Corporation has received 510(k) clearance from 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 tissues 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.