Masimo gets FDA 510(k) clearance for O3 regional oximetry to monitor cerebral oxygenation

14 June 2016 (Last Updated June 14th, 2016 18:30)

Masimo has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its O3 regional oximetry to monitor cerebral oxygenation.

O3 regional Oximetry

Masimo has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its O3 regional oximetry to monitor cerebral oxygenation.

Masimo's regional oximetry enables monitoring of cerebral oxygenation, which is considered important to help reduce the risk of secondary hypoxic and ischemic brain damage following severe head injury.

The O3 regional oximetry features a near-infrared spectroscopy (NIRS), which continuously monitors the absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region.

"Clinicians can simultaneously access rSO2 and other measurements all in one monitoring platform."

A study involving 27 patients measured the difference between the cerebral oxygen saturation measurements obtained from O3 with saturations from blood samples (SavO2) through induced hypoxia.

Studies were later conducted on the O3 regional oximetry involving 74 subjects, which demonstrated the O3's consistent and relative accuracy.

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."

The company noted that currently O3 is suited for adults weighing 40kg or more.


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