Medical technology manufacturer Masimo earned FDA clearance this week for its O3 regional oximetry technology.
O3 uses near-infrared spectroscopy to measure brain tissue oxygen saturation. The technology will allow clinical staff to detect regional hypoxemia that conventional pulse oximetry methods cannot detect.
The device displays both oxygen saturation and pulse oximetry levels, along with the difference between the two. Users can set a baseline number and the tool will monitor how far the patient strays from the preset. O3 also indicates the length of time and extent that the patient has been poorly oxygenated.
In a study of 27 subjects, Daniel Redford, MD, University of Arizona (Phoenix), compared the cerebral oxygen saturation measurements from the device with saturations obtained from blood samples through induced hypoxia. O3 provided an absolute root-mean-squared error of four percent and a relative root-mean-squared error of about two percent.
A follow-up study with 74 subjects showed that O3 sustained its absolute and relative accuracy.
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