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Medical Devices / Submissions and Approvals

FDA Clears Masimo’s Updated Cerebral Oxygenation Monitor

Sept. 11, 2019
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The FDA has cleared additional measurements by Masimo’s O3 cerebral oxygenation monitor, enabling the device to show more information on changes in the blood used to calculate cerebral oxygen saturation.

The agency has cleared the indices for changes in deoxyhemoglobin, oxyhemoglobin, and the sum of deoxyhemoglobin and oxyhemoglobin.

The O3 uses spectroscopy to monitor cerebral oxygenation in situations where peripheral pulse oximetry may not fully indicate oxygen levels in the brain, the company said.

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