View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
June 14, 2016

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

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network