Somanetics Corp. (SMTS) said Thursday that it has received FDA's 510(k) clearance to expand the labeling for its INVOS Cerebral/Somatic Oximeter. The new labeling will include improved patient outcomes and real-time measurement accuracy.
Somanetics said the changes make INVOS System the only commercially-available cerebral/somatic oximeter backed by an improved patient outcomes claim, and the only cerebral/somatic system cleared for use on neonates less than 2.5 kg.
The INVOS or 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.
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 at risk for reduced or absent blood flow.
The new labeling also reflects 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 labeling also removed "not demonstrated in disease states" from the indication for patients weighing greater than 2.5 kg.
SMTS is currently trading at $14.87, up 10 cents.
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