Zynex has completed its clinical verification trial for the NiCO laser-based pulse oximeter, a device designed to measure blood oxygen levels more accurately.
RT’s Three Key Takeaways:
- Laser Technology for Improved Accuracy: The NiCO pulse oximeter uses laser technology to measure blood oxygen levels directly, aiming to overcome limitations of traditional LED oximeters, particularly for individuals with darker skin pigmentation.
- Clinical Trial Completion Advances FDA Submission: The completed verification trial at Duke University fulfills a key FDA requirement, enabling Zynex to move forward with its 510(k) clearance application.
- Market Impact and Broader Potential: NiCO would represent Zynex’s first monitoring product to enter a growing market.
Medical technology company Zynex Inc announced it has completed its clinical verification trial for its NiCO pulse oximeter, overseen by anesthesiologist David MacLeod, MBBS, at Duke University.
Trial completion is required by the US Food and Drug Administration 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 typically estimate oxygenation levels using LEDs. LED pulse oximeters have been shown to mismeasure oxygen levels in several populations, most prominently in individuals with darker skin pigmentation.
“The completion of our verification study is a pivotal event for Zynex Monitoring and the result of an enormous team effort. The bulk of the hard work is behind us at this point as we turn to submit NiCO for FDA clearance officially,” says Donald Gregg, president of Zynex Monitoring Solutions, in a release.
Thomas Sandgaard, founder and CEO of Zynex, adds in a release, “NiCO will be the first Zynex monitoring product to enter a mature and growing market whose entry will be enabled by its game-changing capabilities. We are excited to finally have all the required clinical studies behind us as we prepare our application for FDA clearance.”
