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Somanetics Announces New FDA 510(K) Clearance
Date:4/16/2009

cision. 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."

Barrett continues, "Our expanded indication reinforces the device's applicability for on-label treatment of patients at any weight. For patients above 2.5 kilograms, including adults, children and most infants, our proprietary algorithm generates accurate, real-time measurements for immediate use by the care team. In patients below 2.5 kilograms, which is extremely common in our neonatal market, clinicians may use our device on-label as a trend monitor."

The labeling also removed "not demonstrated in disease states" from the indication for patients weighing greater than 2.5 kg, and includes additional 510(k) language on these three points:

  • The measurement of regional cerebral oxygen saturation (rSO2) is an indication of whether oxygen delivery to the brain is adequate. Prolonged declines in rSO2 are indicative of, or may result in, potential brain injury.

  • When used as an indication of compromised cerebral oxygenation, interventions to return the patient's rSO2 to baseline using the INVOS System have been shown to improve outcomes after surgery.

  • In neonates, infants and children, cerebral and somatic rSO2 provide noninvasive indications of oxygen changes in the cerebral and peripheral circulatory systems and may provide an early indication of oxygen deficits associated with impending shock states and anaerobiosis.

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