FDA Cleared

Masimo wins expanded clearance for O3 oximetry device

Masimo (NSDQ:MASI) said today that its O3 regional oximetry device has been cleared for three additional indices — delta cHb, delta HHb, and delta O2Hb.

These indices provide clinicians with greater visibility into changes in the underlying oxyhemoglobin and deoxyhemoglobin components used to calculate cerebral oxygen saturation, or rSO2, the Irvine, Calif.-based company said. The additions will also allow clinicians to view the relative contribution of each component to a patient’s overall rSO2.

O3 is FDA-cleared for the monitoring of cerebral oxygenation and may be helpful in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygenation of the brain, according to the company.

The system uses near-infrared spectroscopy (NIRS) to monitor and display continuous rSO2 values for each side of the brain. As the degree of oxygenation in cerebral tissue changes, the wavelengths of light absorbed by that tissue and those returned to the O3 sensors also change, forming the basis for the measurement of regional (cerebral) oxygen saturation, the company said.

Until now, rSO2 has been displayed as a single, continuous value for each side of the brain. With these three new indices, O3 can now display information about the changes in the underlying components used to calculate rSO2 values. Delta O2Hb provides an index representing changes in the oxyhemoglobin component of the rSO2 calculation. Delta HHb provides an index representing changes in the deoxyhemoglobin component of the rSO2 calculation. Finally, delta cHb provides an index representing the sum of delta O2Hb and delta HHb.

“We are proud to announce these three O3 indices, which we developed in response to requests from clinicians,” said Masimo CEO Joe Kiani in a news release. “Now, for the first time, clinicians can monitor not just overall cerebral oxygen saturation but also have access to additional data on the changes in the underlying oxyhemoglobin and deoxyhemoglobin components that make up rSO2 values — data that we hope can help provide additional insight into patient status.”

Original Article: (https://www.massdevice.com/masimo-wins-expanded-clearance-for-o3-oximetry-device/)

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