Masimo announced on August 19, 2025, that its O3® Regional Oximetry received FDA 510(k) clearance for expanded indications of its delta hemoglobin parameters. These parameters, ΔcHb, ΔHHb, and ΔO2Hb, provide clinicians with additional insight into changes in tissue oxygen saturation.
With this expanded clearance, the capability is now available for both cerebral and somatic applications, as well as for all patient populations, including pediatric and neonatal patients. This broadens the utility and market reach of the O3 technology.
The combination of O3 Regional Oximetry and SedLine® Brain Function Monitoring on Masimo's Root® platform now offers a comprehensive brain health solution. This enhancement allows clinicians to better understand the underlying mechanisms of tissue oxygenation changes, supporting more informed clinical assessments and interventions.
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