Zynex Inc. Submits FDA 510(k) Application for Innovative NiCO Laser Pulse Oximeter, Marking Key Milestone in Regulatory Review

Reuters
15 May
Zynex Inc. Submits FDA 510(k) Application for Innovative NiCO Laser Pulse Oximeter, Marking Key Milestone in Regulatory Review

ENGLEWOOD, Colo., May 12, 2025 - Zynex, Inc. $(ZYXI)$, a leader in medical technology, has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its NiCO™ Noninvasive CO-Oximeter device. This submission is a significant step in the company's efforts to innovate within the field of patient monitoring. The NiCO Laser Pulse Oximeter is designed to provide more reliable and accurate oxygen status information, potentially revolutionizing the pulse oximetry market, which is projected to grow from $2.8 billion today to $4.3 billion by 2027. The device aims to enhance patient care by offering real-time data on various hemoglobin species, enabling earlier detection of conditions such as hypoxia and hyperoxia.

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