Zynex Inc (NASDAQ:ZYXI) announced that it has completed the clinical verification trial for its NiCO pulse oximeter, a key milestone required to get market clearance for the device from the US Food and Drug Administration (FDA).
The verification trial was overseen by anesthesiologist Dr David MacLeod at Duke University.
Zynex said with the trial now completed, its focus will turn to final testing to ensure the operational safety of the device before making a 510(k) submission to the FDA.
The NiCO pulse oximeter uses advanced laser technology to directly measure blood oxygen levels, offering improved accuracy compared to traditional LED-based devices, particularly for 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,” Zynex CEO Thomas Sandgaard said in a statement.
“We are excited to finally have all the required clinical studies behind us as we prepare our application for FDA clearance.”
Donald Gregg, Zynex Monitoring Solutions president, described the completion of the verification study as a “pivotal event” for the company.
“The bulk of the hard work is behind us at this point as we turn to submit NiCO for FDA clearance officially,” Gregg said.