Zynex has completed the clinical verification trial of its pulse oximeter, NiCO, marking a significant milestone towards the Food and Drug Administration (FDA) clearance.
Overseen by Duke University anaesthesiologist Dr David MacLeod, the trial is a critical step before submitting a 510(k) application to market the device for clinical use.
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The company is currently focusing on final safety testing before the submission.
NiCO was developed by Zynex Monitoring Solutions and employs advanced laser technology for direct measurement of blood oxygenation levels.
This method contrasts with the estimation approach used by conventional LED-based pulse oximeters, which have been noted for inaccuracies, particularly in individuals with darker skin pigmentation.
Zynex Monitoring Solutions president Donald Gregg said: “The completion of our verification study is a pivotal event for Zynex Monitoring and the result of an enormous team effort.
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By GlobalData“The bulk of the hard work is behind us at this point as we turn to submit NiCO for FDA clearance officially.”
The completion of the clinical trial brings the company closer to entering the multi-billion dollar pulse oximetry market with its technology.
Zynex CEO and founder Thomas Sandgaard said: “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.”
The company received the FDA clearance for its TensWave device in September.
Available by prescription, this device is designed to offer pain relief via transcutaneous electrical nerve stimulation (TENS) therapy.
Founded in 1996, Zynex has been developing, manufacturing, marketing and selling medical devices for pain management and rehabilitation.
The company also offers non-invasive monitoring systems for hospitals, including sepsis, fluid, and laser-based pulse oximetry solutions.
