Zynex Completes Its Laser Pulse Oximetry Trial

Zynex Inc. has completed its clinical verification trial for the NiCO pulse oximeter, which was overseen by anesthesiologist Dr. David MacLeod at Duke University.

Trial completion is a key milestone required by the U.S. Food and Drug Administration (FDA) prior to submission of a 510(k) for clearance to market and sell the NiCO device for clinical use. With the study completed, Zynex is now conducting final testing to ensure NiCO’s operational safety before submitting a 510(k) application to the FDA.

“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,” Zynex Monitoring Solutions President Donald Gregg said.

Zynex’s NiCO pulse oximeter uses highly precise laser technology to measure blood oxygenation levels directly, as opposed to current pulse oximeter products, which only 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.

“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,” Zynex Founder/CEO Thomas Sandgaard stated.

Zynex Monitoring Solutions’ NiCO product line is a strategic investment for Zynex to enter the multi-billion dollar pulse oximetry market with new pulse oximetry technology. The company is confident the clinical value of NiCO’s precision, accuracy, and safety will provide the right entry into this market space.

Founded in 1996, Zynex develops, manufactures, markets, and sells medical devices used for pain management and rehabilitation as well as non-invasive fluid, sepsis, and laser-based pulse oximetry monitoring systems for use in hospitals.