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Masimo Announces FDA 510(k) Clearance Of Expanded Indications For Delta Hemoglobin Parameters Provided With O3 Regional Oximetry

Author: Benzinga Newsdesk | August 19, 2025 08:10am

Now Available for Both Cerebral and Somatic Applications and for All Patient Populations, O3's Delta Hemoglobin Parameters Offer Clinicians Additional Insight Into Changes in Tissue Oxygen Saturation

Masimo (NASDAQ:MASI) today announced the FDA 510(k) clearance of expanded indications for the delta hemoglobin parameters provided with O3® Regional Oximetry. The parameters (ΔcHb, ΔHHb, and ΔO2Hb) display relative changes in hemoglobin that can help clinicians identify the underlying mechanisms responsible for changes in tissue oxygen saturation. With this latest clearance, this capability is now available for use in both cerebral and somatic applications as well as for all patient populations, including pediatric and neonatal patients.

Posted In: MASI

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