Masimo wins expanded FDA nod for O3 regional oximetry

Masimo (Nasdaq: MASI)+ announced today that it received FDA 510(k) clearance for expanded indications for its O3 regional oximetry technology

The expanded indication covers the delta hemoglobin parameters provided with the oximetry platform. 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.

Masimo says the latest clearance makes this capability available for use in both cerebral and somatic applications. It also covers all patient populations, including pediatric and neonatal patients. O3 originally received FDA clearance in 2020.

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