Masimo Announces CE Marking of O3 Regional Oximetry
In an abstract presented at the Society for Technology in Anesthesia 2014 Annual Meeting in Orlando, Fla., Dr. Daniel Redford from the University of Arizona evaluated cerebral oxygen saturation on 23 subjects and 202 paired measurements of rSO2 from O3 regional oximetry and reference arterial and venous blood samples (SavO2).1 Reference blood samples were taken from both an arterial cannula placed in the radial artery and a catheter placed in the internal jugular bulb vein, obtained at baseline and after a series of increasingly hypoxic states. O3 regional oximetry had an absolute accuracy of 4.0% and trend accuracy of 2.1%.
"Masimo O3 regional oximetry will have the unique ability to measure both rSO2 and Masimo SET® SpO2 pulse oximetry simultaneously from the same forehead sensor," said Dr. Michael Ramsay, M.D., Chief of the Department of Anesthesiology and Pain Management at Baylor University Medical Center in Dallas. "This may provide the anesthesiologist or perfusionist for the first time with a differential analysis of regional to central oxygen saturation monitoring that could help the clinician in maintaining brain oxygenation and safe cerebral perfusion during cardiac procedures."
O3 regional oximetry is currently intended for use in subjects larger than 40 kg (88 lbs) and has not yet received FDA 510(k) clearance.
Joe Kiani, CEO and Founder of Masimo, said, "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. We look forward to partnering with key hospitals around the world to demonstrate O3's technical and clinical advantages."