Zynex, Inc. announced the submission of its 510(k) application to the U.S. Food and Drug Administration (FDA) for its NiCO™ Noninvasive CO-Oximeter device. This submission marks a historic milestone in the evolution of pulse oximetry and a major breakthrough for the company's patient monitoring products. The pulse oximetry market is one of the world's largest medical device markets, with an estimated accessible market of over $2.8 billion today, projected to grow to $4.3 billion by 2027.
Zynex's NiCO device utilizes highly precise laser technology to directly measure fractional blood oxygenation levels, offering a significant advantage over current LED-based pulse oximeters. Traditional LED devices have faced scrutiny for inaccuracies, particularly in individuals with darker skin pigmentation and at low oxygen perfusion levels. The FDA has issued updated recommendations urging manufacturers to address these issues with expanded testing and higher accuracy standards.
The laser-based technology in NiCO is designed to provide accurate oxygen measurements for patients with dark skin and to measure both oxygen and carbon monoxide non-invasively and instantaneously. This capability could reduce the need for painful blood samples and delayed lab results, improving patient care and potentially saving lives. The company emphasizes that NiCO's performance is not skewed by pigments like melanin or nail polish, ensuring trustworthy measurements and eliminating harmful pigmentation bias problems.
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