Zynex submits FDA application for NiCO, a breakthrough non-invasive co-oximeter

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2d ago 7:06

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Zynex Inc CEO Thomas Sandgaard joined Steve Darling from Proactive to share a significant development: the company has officially submitted its NiCO™ Noninvasive CO-Oximeter device to the U.S. Food and Drug Administration (FDA) for clearance. This submission represents a major milestone in Zynex’s pursuit to revolutionize patient monitoring through advanced technology that addresses longstanding clinical challenges in pulse oximetry. NiCO™ leverages Zynex’s proprietary laser technology to directly measure fractional oxygenated hemoglobin (O₂Hb), enabling accurate arterial saturation readings even in the presence of dyshemoglobins like carboxyhemoglobin (COHb), which may indicate CO poisoning. Unlike traditional LED-based pulse oximeters that estimate SpO₂, NiCO™ provides more precise and reliable data—reducing reliance on invasive diagnostics. It is also designed to overcome known limitations of conventional pulse oximeters, delivering consistent accuracy across all patient demographics, including individuals with darker skin pigmentation. Sandgaard emphasized the critical need for this innovation, especially in the wake of clinical studies conducted during and after the COVID-19 pandemic, which exposed major flaws in conventional pulse oximeters. These studies revealed that oxygen saturation was frequently overestimated in individuals with darker skin tones, potentially leading to delayed or improper treatment. In response to these findings, the FDA issued updated recommendations earlier this year, urging medical device manufacturers to improve testing protocols and enhance accuracy standards. Zynex’s NiCO™ device directly addresses these new guidelines with a focus on inclusivity, clinical reliability, and faster diagnostics. Beyond addressing health equity, the NiCO™ device also offers a compelling clinical benefit: the ability to detect carbon monoxide poisoning instantly and noninvasively—an advancement that could eliminate delays caused by traditional blood-based diagnostic methods. The pulse oximetry market, currently valued at over $2.8 billion, is expected to grow to $4.3 billion by 2027, driven by increasing demand in both hospital and outpatient settings. Zynex’s FDA submission puts the company at the forefront of this expanding market, signaling its commitment to providing innovative, high-impact solutions for modern patient care. #proactiveinvestors #zynexinc #nasdaq #zyxi #healthcare #MedicalDevices #FDAApproval #PulseOximeter #NonInvasiveTech #HealthcareInnovation #ThomasSandgaard #Oximetry #PatientMonitoring #ProactiveInvestors

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