Somanetics gets FDA approval for expanded use of Invos technology

By E. Janene Geiss

Philadelphia, Nov. 7 - Somanetics Corp. announced Monday that is has received 510(K) clearance from the U.S. Food and Drug Administration to market the Invos technology to monitor changes in blood oxygen saturation in regions of the body other than the brain.

This new application of the Invos technology is intended as an adjunct trend monitor of hemoglobin oxygen saturation of blood in skeletal muscle tissue beneath the sensor in infants, children and adults at risk of reduced-flow or no-flow ischemic states in critical care settings, officials said in a company news release.

"Our initial focus will be to capitalize on emerging opportunities to combine cerebral and skeletal muscle oxygen monitoring for the benefit of infants and children in the intensive care setting. There may also be numerous other applications where monitoring of the skeletal muscle tissue may assist in important clinical decision making," said Bruce Barrett, president and chief executive officer of Somanetics, in the release.

The company developed and markets the Invos Cerebral Oximeter, which has been used since 1996 in U.S. hospitals, and is the only commercially available monitoring system that noninvasively and continuously monitors changes in patients' regional brain blood oxygen saturation, officials said.

Somanetics, based in Troy, Mich., also markets the CorRestore System, a cardiac implant used in cardiac repair and reconstruction.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.