A Medical Device Daily
Somanetics (Troy, Michigan) reported FDA clearance to expand the labeling for its Invos Cerebral/Somatic oximeter system.
The Invos is a non-invasive 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 to identify oxygen imbalances in tissues beneath the sensor and take necessary corrective action, potentially improving patient outcomes and reducing the costs of care.
"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 President/CEO Bruce Barrett. "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."