US-based Masimo has received CE Mark approval for O3 regional oximetry for use with its Root patient monitoring and connectivity platform.
It is designed to assist clinicians detect regional hypoxemia that pulse oximetry alone can miss.
O3 regional oximetry uses near-infrared spectroscopy (NIRS) in a Masimo Open Connect (MOC-9) module with up to two sensors per module.
The onboard pulse oximetry capability in O3 sensors can automate the differential analysis of regional to central oxygen saturation.
Each sensor contains four light-emitting diodes (LEDs) and two detectors to continuously and simultaneously measure both tissue oxygen saturation (rSO2) and arterial blood oxygenation (SpO2).
The Root patient monitoring allows either one or two O3 MOC-9 modules to be connected, enabling monitoring with as few as one and as many as four sensors.
The O3 regional oximetry is currently intended for use in subjects larger than 40kg (88lb) and is not yet approved in the US.
O3 regional oximetry also demonstrated 4% absolute accuracy and 2.1% trend accuracy in a study presented at Society of Technology in Anesthesia Annual Meeting.
Masimo CEO and founder Joe Kiani said: "We look forward to partnering with key hospitals around the world to demonstrate O3‘s technical and clinical advantages."
Image: Masimo O3 regional oximetry MOC-9 module for the Root patient monitoring and connectivity platform. Photo: courtesy of Masimo Corp.