Englewood, Colo. — Zynex, Inc. has taken a major step forward in the evolution of patient monitoring with the submission of a 510(k) application to the U.S. Food and Drug Administration (FDA) for its NiCO™ device, a laser-based, noninvasive pulse CO-oximeter that could significantly advance the accuracy and inclusivity of oxygen monitoring in clinical care.
The NiCO system represents a major technological shift from traditional LED-based pulse oximeters, which have long faced scrutiny for inaccuracies—particularly in patients with darker skin tones or those experiencing low oxygen perfusion. Zynex’s laser-based approach aims to overcome these shortcomings by directly measuring fractional blood oxygenation levels and detecting dysfunctional hemoglobins, such as carboxyhemoglobin and methemoglobin, without requiring invasive blood tests.
“This 510(k) submission marks a major breakthrough on the path to changing the landscape of patient monitoring,” said Zynex Founder and CEO Thomas Sandgaard. “The NiCO device is our first step in establishing a new standard of care with laser pulse oximetry technology.”
According to the company, the NiCO oximeter is expected to be the first device capable of continuously and non-invasively measuring all four primary hemoglobin species—oxygenated, reduced, carboxy, and methemoglobin. This enables earlier and more accurate detection of conditions such as hypoxia and carbon monoxide poisoning, which could lead to faster intervention and better outcomes.
Traditional pulse oximeters have faced growing criticism in recent years, especially following studies during the COVID-19 pandemic that revealed dangerous disparities in accuracy for patients with darker skin. In response, the FDA issued updated guidance in 2025 urging medical device manufacturers to address these issues with improved testing standards and technological innovation. Zynex’s NiCO device directly responds to that challenge.
“We believe NiCO is a distinct market-disrupting technology,” said Donald Gregg, President of Zynex Monitoring Solutions. “It provides clinicians with comprehensive, real-time data on a patient’s oxygen status, helping to improve accuracy in critical decisions and ultimately enhancing patient care.”
Beyond clinical accuracy, NiCO is positioned to compete in a rapidly expanding market. The pulse oximetry segment is estimated to be worth $2.8 billion today and is projected to grow to $4.3 billion by 2027. Zynex sees even broader opportunity in the total hemoglobin testing space, which could reach up to $34 billion globally.
If approved, NiCO would become a flagship product for Zynex in the patient monitoring field, where pulse oximeters are now considered standard equipment across nearly all hospital and non-hospital settings. The company says it is moving quickly toward commercialization and sees this FDA submission as a significant milestone in its strategy to deliver cutting-edge, equitable medical technologies.
