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Masimo wins de novo authorization for measure of high blood oxygen levels

The ORi device is intended to support standard pulse oximetry by providing additional insights into patients with higher than normal oxygenation.
  • Masimo has received de novo authorization for a device designed to improve the monitoring of blood oxygen in certain situations.
  • The device, ORi, is intended to support standard pulse oximetry by providing additional insights into patients with higher than normal oxygenation, a condition known as hyperoxia. 
  • Patients receiving supplemental oxygen can develop hyperoxia, raising the risk of tissue damage. Physicians have traditionally used blood draws that are analyzed to monitor the condition.

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