Masimo Announces CE Marking for Pediatric O3™ Regional Oximetry

Friday, August 05, 2016

Masimo announced the CE marking for the pediatric indication for O3™ regional oximetry with the O3 pediatric sensor. Regional oximetry, also referred to as tissue or cerebral oximetry, helps clinicians monitor cerebral oxygenation.

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. Early detection and correction of imbalances in oxygen delivery to the brain and vital organs are important tools in helping patients avoid postoperative morbidity and adverse outcomes.1 With the release of the O3 pediatric sensor, O3 regional oximetry monitoring of rSO2 is now available to pediatric patients weighing less than 40 kg (88 lbs).

"O3 regional oximetry provides access to valuable data about cerebral oxygen saturation, and studies have shown that the risks of cerebral desaturations include neurological injury2,3, increased length of hospital stays3, increased time on mechanical ventilation4, and other adverse outcomes5," said Joe Kiani, Founder and CEO of Masimo. "With adult trend accuracy of 3% and absolute accuracy of 4% without controlling CO2, and trend accuracy of 3% in pediatric patients6, Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatric ones."

Masimo O3 regional oximetry and SedLine® brain function monitoring are both available on a single platform, Masimo Root® – opening up a path to better understanding of the brain.

O3 regional oximetry for use with adults weighing 40 kg (88 lbs) or greater has received FDA 510(k) clearance. O3 regional oximetry for use with pediatric patients weighing less than 40 kg (88 lbs) has not received FDA 510(k) clearance; the O3 pediatric sensor is not currently for sale in the United States.

 

Source : masimo.com

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