Masimo (NSDQ:MASI) won European regulatory approval for its O3 regional oximetry, a new oxygen monitor feature for Masimo’s Root patient monitoring system.
The O3 connects to Masimo’s Root patient monitoring system, allowing for up to 4 sensors to be used at one time and using near-infrared spectroscopy to measure tissue oxygen saturation and arterial blood oxygenation.
The device is currently intended for subjects larger than 88lbs and has not yet received FDA 510(k) clearance, according to a press release.
“O3 regional oximetry delivers again on Masimo’s mission to improve patient outcomes and reduce cost of care by taking noninvasive monitoring to new sites and applications," founder and CEO Joe Kiani said in prepared remarks. "We look forward to partnering with key hospitals around the world to demonstrate O3’s technical and clinical advantages."
Irvine, Calif.-based Masimo recently integrated its SET measure-through motion and low perfusion pulse oximetry into Acutronic Medical Systems’ fabian HFO neonatal critical care ventilator. The fabian HFO is now able to collect ventilation and oxygenation patient data in 1 device instead of 2, by connecting the pulse oximetry sensor via USB to the ventilator.
