News
Somanetics expands INVOS system labeling
Troy, Michigan, US
May 27, 2008
Somanetics Corporation has 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 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."
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