Medical technology firm Masimo has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its O3 regional oximetry device.


Regional oximetry, also called as tissue or cerebral oximetry, will help clinicians in monitoring cerebral oxygenation in situations where pulse oximetry alone is not fully indicative of the oxygen in the brain because of several factors like the type of clinical procedure being undertaken.

The near-infrared spectroscopy (NIRS) allows O3 regional oximetry to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region.

In a study on 27 subjects, Daniel Redford of the University of Arizona compared cerebral oxygen saturation measurements obtained from O3 with saturations obtained from blood samples (SavO2) through induced hypoxia.

According to the company, the O3 regional oximetry provided absolute root-mean-squared error of 4% and relative root-mean-squared error of 2.1% in the study.

Follow up studies with O3, which expanded the subject pool to 74 subjects, showed that it maintained absolute and relative accuracy.

Currently, the O3 regional oximetry can be used by adults weighing 40 kg (88 lbs) or more.

Masimo founder and CEO Joe Kiani said: "O3 regional oximetry delivers again on Masimo’s technical prowess and gives clinicians access to valuable, accurate data about cerebral oxygen saturation.

"With the addition of O3 regional oximetry to the Root platform, clinicians can simultaneously access rSO2 and other measurements including SedLine brain function monitoring, Masimo SET SpO2, PVI, and SpHb monitoring – all in one monitoring platform."

Image: Masimo Root with O3 regional oximetry and SedLine brain function monitoring. Photo: courtesy of Masimo.