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Medical Devices / Submissions and Approvals

FDA Clears Masimo’s Cerebral Oxygenation Monitor for Neonates

June 11, 2019
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The FDA granted Masimo additional 510(k) clearance for its O3 Regional Oximetry platform for monitoring brain oxygen levels in neonatal patients.

The O3 sensors use near-infrared spectroscopy to monitor the hemoglobin oxygen saturation of blood on both sides of the brain. Because neonatal pathology is often brain-related, the sensors  may be “particularly helpful” in providing insight into neonatal patient status, the company said.

The sensors are now available in a smaller size and flexible design, allowing them to fit comfortably on the foreheads of neonatal patients that weigh less than 22 pounds.

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