Zynex Inc (NASDAQ:ZYXI) announced it has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its NiCO Noninvasive CO-Oximeter device.
The NiCO device utilizes laser pulse oximetry technology, which Zynex said can address long-standing limitations of traditional LED-based pulse oximeters, including inaccuracy in patients with darker skin tones and difficulty detecting certain hemoglobin variants.
The company noted that its laser-based system directly measures fractional blood oxygenation levels, avoiding interference from pigments such as melanin or substances like nail polish.
According to Zynex, the NiCO is expected to be the first product capable of continuously and non-invasively measuring all four primary hemoglobin species: oxygenated hemoglobin, reduced hemoglobin, carboxyhemoglobin, and methemoglobin.
The device also aims to improve the detection of hypoxia, hyperoxia, and dyshemoglobinemia, potentially reducing the reliance on blood samples and lab processing in cases such as carbon monoxide poisoning.
"This 510(k) submission marks a major breakthrough on the path to changing the landscape of patient monitoring," Zynex CEO Thomas Sandgaard said in a statement.
"Enormous thanks are owed to the tireless work of our tremendous Zynex Monitoring team, and the day we see NiCO in clinical care is approaching at an exciting pace."
Donald Gregg, Zynex Monitoring Solutions president, described NiCO as a “distinct market-disrupting technology” which could improve patient care for hospital and non-hospital providers in numerous medical settings.
"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,” Gregg said.
“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.”
Shares of Zynex added 6.3% in early trade on Monday following the update.