Zynex’s NiCO™ Laser Pulse Oximeter represents a major innovation in the field of patient monitoring, utilizing advanced laser technology to overcome the well-documented limitations of traditional LED-based pulse oximeters. Unlike conventional devices that estimate oxygen saturation levels, NiCO directly measures fractional oxygenation and all four primary hemoglobin species—oxygenated, reduced, carboxyhemoglobin, and methemoglobin. This innovation addresses serious accuracy concerns, especially in patients with darker skin pigmentation and those exposed to carbon monoxide or other hemoglobin-disrupting substances. By providing real-time, non-invasive, and comprehensive data, NiCO introduces a new standard in monitoring vital signs.

The importance of this development is profound. Traditional pulse oximeters have faced growing scrutiny due to their inaccuracy in diverse patient populations, which was highlighted during the COVID-19 pandemic. This has led regulatory bodies like the FDA to call for improved technologies that are more accurate and equitable. NiCO directly answers this call with a system that not only eliminates pigmentation bias but also detects life-threatening conditions earlier by measuring dysfunctional hemoglobins. Such precision in monitoring can lead to quicker diagnoses, improved patient outcomes, reduced healthcare costs, and more equitable care across different demographics.

In terms of usage, NiCO is designed for both hospital and non-hospital settings, making it highly versatile for various clinical environments. The device enables clinicians to continuously monitor patients with high-risk conditions such as carbon monoxide poisoning or severe respiratory issues without resorting to invasive blood draws. Its application spans emergency departments, operating rooms, intensive care units, and even outpatient care, providing vital data instantly and reliably. With this FDA submission, Zynex is poised to transform how oxygen levels are measured and managed, potentially replacing current standards with a more accurate and inclusive solution.