Press release
Masimo O3® Regional Oximetry Receives FDA Clearance for Somatic Applications and Measurement of Relative Changes in Cerebral Hemoglobin
IRVINE, Calif.--(BUSINESS WIRE)-- Masimo (NASDAQ: MASI) today announced that O3® Regional Oximetry has received FDA clearance for expanded use in monitoring
About this update from Masimo Corporation
[{"type":"text","content":" IRVINE, Calif.--(BUSINESS WIRE)--\nMasimo (NASDAQ: MASI) today announced that O3® Regional Oximetry has received FDA clearance for expanded use in monitoring somatic tissue oxygenation saturation in all patient populations and monitoring relative changes in hemoglobin, oxyhemoglobin, and deoxyhemoglobin in adult brains. With this FDA clearance, O3 is now indicated for use in both cerebral and somatic applications, both in the U.S. and in CE mark countries, for all patient populations.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200831005390/en/Masimo Root® with O3® Regional Oximetry (Photo: Business Wire)\n\nO3 Regional Oximetry provides regional or tissue hemoglobin oxygen saturation with a trending specification of 3% ARMS* (cerebral and somatic, all ages) and absolute accuracy specifications of 4% ARMS (cerebral, adults) and 5% ARMS (cerebral, pediatric patients) through the use of O3 multi-wavelength sensors and O3 Regional Oximetry near-infrared spectroscopy (NIRS) technology. Unlike peripheral pulse oximetry, which reflects the body’s general arterial blood oxygenation, O3 provides information about the local tissue’s hemoglobin oxygen saturation, both in cerebral and somatic applications. This information provides additional insight that may help inform clinicians of changes in cerebral or somatic tissue oxygen levels. Monitoring renal tissue oxygenation in neonates has been found to help provide early warning of renal dysfunction.1 Monitoring both brain and somatic tissue oxygenation simultaneously may further improve clinicians’ ability to provide rapid and accurate care.2\n\n\nAndré Denault, MD, PhD, Department of Anesthesiology, Critical Care Program at the Montreal Heart Institute and Central Hospital of the University of Montreal, said, “There is a growing interest in the use of somatic NIRS owing to the association of cerebral and somatic desaturation with unfavorable outcomes in shock states. As an addition to O3 cerebral oximetry, the somatic component could serve as an earlier warning of impaired tissue perfusion. Somatic NIRS has been validated as a monitor of peripheral perfusion and shows an excellent correlation with peripheral perfusion compared with radionuclide plethysmography. As previously reported,3 cerebral and somatic NIRS combined wi...