Zynex has announced the submission of a 510(k) application to the US Food and Drug Administration (FDA) for its NiCO non-invasive CO-oximeter device.
This move is said to align with the company’s mission of enhancing individual outcomes and quality of care with its monitoring solutions.
Pulse oximeters are said to be currently used in every clinical care area in both hospital and non-hospital settings.
According to Zynex, pulse oximetry, a critical medical device market, has faced challenges with the accuracy of current devices, especially for dark skinned patients.
Post-Covid-19, clinical studies have revealed that traditional light-emitting diode (LED)-based pulse oximeters can inaccurately interpret oxygenation levels in dark skinned patients and those with low oxygen perfusion.
In light of this, the FDA has called for improved accuracy in pulse oximetry devices. Earlier this year, the agency issued updated device recommendations, urging the manufacturers to address the concerns in current and new solutions.
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By GlobalDataZynex noted that its laser technology will facilitate the accurate measurement of oxygen levels for patients with darker skin pigmentation.
In carbon monoxide (CO) poisoning cases, its device not only offers instantaneous and non-invasive outcomes, but it claims to measure oxygen and CO, minimising the requirement for collecting samples of blood and waiting for the laboratory outcomes.
The company鈥檚 device is anticipated to provide clinicians with accurate data, measuring all four primary haemoglobin species using patented laser pulse oximetry technology and allows for earlier detection of hyperoxia and hypoxia.
Alongside oxygenated haemoglobin, the NiCO laser pulse oximeter measures levels of decreased haemoglobin and dysfunctional haemoglobins such as carboxyhaemoglobin and methaemoglobin.
Zynex monitoring solutions president Donald Gregg said: “We believe NiCO is a distinct market-disrupting technology and can provide significant improvements to patient care for hospital and non-hospital providers in numerous medical settings.”
