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Masimo Gains Expanded Clearance for Oxygen Monitor

September 2, 2020

Masimo’s O3 Regional Oximetry has received 510(k) clearance from the FDA for use in monitoring somatic tissue oxygenation saturation in all patient populations. The product was previously cleared for cerebral applications.

Unlike peripheral pulse oximetry, which measures the body’s arterial blood oxygenation, O3 provides information about the local tissue’s hemoglobin oxygen saturation.

Monitoring both brain and somatic tissue oxygenation simultaneously may further improve clinicians’ ability to provide rapid and accurate care, the company said.

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