FDA Approves New Labeling for Somanetics’ INVOS Oximeter
April 17, 2009 - Somanetics Corp. has received FDA 510(k) approval to expand the labeling for its INVOS Cerebral/Somatic Oximeter.
The new labeling allows a claim of improved patient outcomes after surgery when the INVOS System is used to manage therapies in patients above 2.5 kilograms (kg) at risk for reduced or absent blood flow. Its indications for use now reflect the INVOS System's ability to generate accurate real-time measurements of blood oxygen saturation in this same patient population, in addition to its previous clearance as a trend monitor in any individual.
The INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter noninvasively monitors site-specific blood oxygen levels to help surgical and critical care teams protect their patients against brain and vital organ area damage, or even death.
“We use the INVOS System routinely in all our cardiac surgeries in an effort to protect patients from ischemic brain complications. I suspect today's news will spark further adoption of the technology by the medical community,” said Marc S. Kanchuger, M.D., associate professor and chief of cardiothoracic surgery and transplant anesthesia at NYU Medical Center.
For more information: www.somanetics.com.
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