Dive Brief:
- 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.
Dive Insight:
Masimo’s business is built on pulse oximetry technology, but it acknowledges the limitations of the tool for monitoring certain levels of blood oxygen. SpO2, the reading captured by pulse oximeters, is an effective way to show if a patient has normal or low levels of blood oxygen. However, the measurement is ill-equipped to assess above-normal levels of oxygen.
Prolonged exposure to high levels of supplemental oxygen can lead to hyperoxia, a condition associated with damage to the lung and other organs. Physicians perform arterial blood gas analysis to monitor high oxygen levels, but the test is invasive and only performed intermittently.
Masimo saw an opportunity for a non-invasive, continuous approach to the monitoring of hyperoxia. The result is ORi, a noninvasive, continuous parameter enabled by Masimo’s pulse oximetry platform. ORi uses the multiple wavelengths of light covered by the platform to provide physicians with data on the risk of hyperoxia. The Food and Drug Administration recently authorized the technology.
“Since ORi’s availability and success outside the U.S., perioperative clinicians in the U.S. have been waiting for a way to noninvasively monitor patients under supplemental oxygen beyond the limits of SpO2. We are thrilled that U.S. clinicians can now integrate ORi monitoring … into their oxygenation monitoring practices,” Masimo CEO Joe Kiani said in a statement.
The FDA authorized ORi via its de novo pathway. As such, the authorization creates a route for other companies to bring similar medical devices to market via the 510(k) clearance pathway.