Zynex, Inc. (ZYXI), a medical technology company, Monday announced it has submitted a 510(k) application to the U.S. Food and Drug Administration 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 (CO) 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.
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