Zynex (NASDAQ:ZYXI) announced it has submitted a 510(k) application to the FDA for its NiCO Noninvasive CO-Oximeter device.
The company stated that the submission marks a historic milestone in the evolution of pulse oximetry, and a major breakthrough in its mission to improve the quality and care of patient outcomes through patient monitoring products. According to Zynex, pulse oximetry is one of the world’s largest medical device markets and current devices have long been under scrutiny for their inaccuracy and limitations.
“We believe NiCO is a distinct market disrupting technology and can provide significant improvements to patient care for hospital and non-hospital providers in numerous medical settings,” said Donald Gregg, president of Zynex Monitoring Solutions.
Mr. Gregg added, “Clinical studies have shown the Zynex NiCO Laser Pulse Oximeter is groundbreaking in providing more reliable, comprehensive, and accurate information about a patient’s oxygen status by continuously measuring all four primary hemoglobin species. The real-time display of oxygenated hemoglobin, reduced hemoglobin, carboxyhemoglobin and methemoglobin will assist clinicians in earlier and more accurate detection of hypoxia and hyperoxia, which can save lives, lower costs, and enhance overall patient care efficiency.”
