Zynex, Inc. (NASDAQ: ZYXI) has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its groundbreaking NiCO™ Noninvasive CO-Oximeter device, marking a significant advancement in pulse oximetry technology that could transform patient monitoring across healthcare settings.
The submission represents a major milestone for the Colorado-based medical technology company in addressing longstanding accuracy issues with conventional pulse oximeters, particularly their documented failure to provide reliable readings for patients with darker skin tones.
Revolutionary Laser Technology Addresses Healthcare Disparities
NiCO™ utilizes proprietary laser technology to directly measure fractional oxygenated hemoglobin (O₂Hb), providing more accurate arterial saturation readings compared to traditional LED-based pulse oximeters that merely estimate SpO₂. This technological breakthrough comes at a critical time, as clinical studies following the COVID-19 pandemic exposed significant flaws in conventional devices.
"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," said Donald Gregg, President of Zynex Monitoring Solutions.
Research published in the New England Journal of Medicine and other medical journals revealed that conventional pulse oximeters frequently overestimate oxygen saturation in individuals with darker skin pigmentation, potentially leading to delayed or inadequate treatment. In response, the FDA issued updated recommendations earlier this year urging manufacturers to address these biases and improve accuracy standards.
Beyond Skin Tone: Detecting Carbon Monoxide Poisoning
Beyond addressing racial bias in healthcare technology, NiCO™ offers another significant clinical advantage: the ability to detect carbon monoxide poisoning non-invasively and in real-time.
The device measures all four primary hemoglobin species, including carboxyhemoglobin (COHb) and methemoglobin, which conventional oximeters cannot detect. This capability could eliminate the delays associated with traditional blood-based diagnostic methods for carbon monoxide poisoning, potentially saving lives in emergency situations.
"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," Gregg explained.
Market Potential and Future Applications
The pulse oximetry monitoring market represents a substantial opportunity, currently valued at over $2.8 billion and projected to reach $4.3 billion by 2027. Pulse oximeters are used in virtually every clinical care area in both hospital and outpatient settings.
Thomas Sandgaard, Zynex Founder and CEO, emphasized the significance of this development: "This 510(k) submission marks a major breakthrough on the path to changing the landscape of patient monitoring. The day we see NiCO in clinical care is approaching at an exciting pace."
The company also sees potential for its laser-based technology to expand into the total hemoglobin testing market, which represents an additional $2-3 billion opportunity.
Technical Advantages Over Conventional Devices
Unlike current LED-based pulse oximeters, NiCO™'s laser technology is not affected by external factors such as melanin or nail polish, resulting in more reliable measurements across diverse patient populations. The device is designed to perform consistently even in patients with low oxygen perfusion, another limitation of conventional oximeters.
The technology directly addresses the FDA's recent call for improved testing protocols and enhanced accuracy standards in pulse oximetry devices, positioning Zynex at the forefront of innovation in this essential medical technology.
Addressing a Critical Healthcare Need
The submission comes at a time of heightened awareness regarding healthcare disparities and the need for medical technologies that work effectively for all patients regardless of skin tone or other physical characteristics.
By developing a device that provides accurate readings across diverse patient populations, Zynex is addressing a critical healthcare equity issue while potentially improving diagnostic capabilities and treatment outcomes for conditions ranging from respiratory distress to carbon monoxide poisoning.
As the FDA review process proceeds, healthcare providers and patient advocates will be watching closely to see if this technological breakthrough can deliver on its promise to establish a new standard in patient monitoring that works reliably for everyone.
