The approval has been granted for the pediatric indication for O3 regional oximetry with the O3 pediatric sensor.
By using near-infrared spectroscopy (NIRS), the O3 regional oximetry will 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 will allow to avoid postoperative morbidity and adverse outcomes in the patients.
Masimo said the O3 regional oximetry monitoring of rSO2 is now available to pediatric patients weighing less than 40 kg (88 lbs) with the release of the O3 pediatric sensor.
Masimo O3 regional oximetry, along with SedLine brain function monitoring, is available on a single platform called Masimo Root.
Masimo founder and CEO Joe Kiani said: "O3 regional oximetry provides access to valuable data about cerebral oxygen saturation, and studies have shown that the risks of cerebral desaturations include neurological injury, increased length of hospital stays3, increased time on mechanical ventilation4, and other adverse outcomes.
"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."
In June, Masimo received 510(k) clearance from the US Food and Drug Administration (FDA) for the O3 regional oximetry device.
The approval was granted for use with adults weighing 40kg or greater, while it has not yet secured FDA approval for use with pediatric patients weighing less than 40 kg.
Image: Masimo Root with O3 regional oximetry with pediatric sensor. Photo: courtesy of Masimo.
