Zynex (ZYXI) has completed its clinical verification trial for their NiCO pulse oximeter overseen by anesthesiologist Dr. David MacLeod at Duke University. Trial completion is a key milestone required by the FDA prior to submission of a 510(k) for clearance to market and sell the NiCO device for clinical use. With the completion of this study, Zynex now turns to final testing to ensure the operational safety of the device prior to 510(k) submission. Zynex’s NiCO pulse oximeter utilizes laser technology to measure blood oxygenation levels directly, as opposed to current pulse oximeter products, which only estimate oxygenation levels using LEDs.
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Read More on ZYXI:
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