Fierce Biotech February 12, 2024
Andrea Park

About a week after the FDA convened its latest meeting to discuss strategies for reducing racial biases in widely available pulse oximetry technology, Masimo has released new study data suggesting that such measures won’t be needed for its own blood oxygen sensors.

The new results build on previous analyses of the same data set, comprising 39 Black patients and 36 white patients who repeatedly used Masimo’s SET pulse oximeters—alongside arterial blood gas measurements for comparison—between 2015 and 2021, for a total of more than 7,000 paired readings.

And, as with the study’s previous findings, according to Masimo’s announcement late last week, the latest round of results uphold the company’s claim that its pulse oximeters churn out readings with no significant...

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Topics: FDA, Govt Agencies, Medical Devices, Patient / Consumer, Provider, Survey / Study, Trends
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