Zynex submitts application to FDA for its Noninvasive CO-Oximeter device

Zynex (ZYXI) announced it has submitted a 510 application to the FDA for its NiCO, Noninvasive CO-Oximeter device. This submission marks a historic milestone in the evolution of pulse oximetry and a major breakthrough for the Company in its mission to improve the quality of care and patient outcomes through its patient monitoring products. Pulse oximetry is one of the world’s largest medical device markets and current devices on the market have long been under scrutiny for their inaccuracy and limitations. Zynex’s laser technology enables oxygen levels to be measured accurately for patients with dark skin. In cases of carbon monoxide poisoning, not only are the measurements non-invasive and results instantaneous, but both oxygen and CO are measured accurately, potentially reducing the need for taking blood samples and having to wait for the lab results. Highly precise laser technology directly measures fractional blood oxygenation levels, rather than the current LED technology which estimates functional oxygen saturation, giving clinicians a more complete, reliable and accurate overview of the patient’s real-time oxygenation status.