Zynex Announces First Enrollment in an Apheresis Blood Donation Clinical Trial for Its Fluid Monitoring System
January 11, 2022 at 09:00 am
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Zynex, Inc. reported it has started enrollments in a clinical trial aimed at further characterizing the performance of its fluid monitoring system, CM-1500. The study, conducted at Vitalant Research Institute (the research arm of Vitalant), tracks changes in the device's patented Relative Index during apheresis blood donation procedures. The company obtained FDA clearance of the fluid monitoring system in February 2020.
The CM-1500 is a non-invasive monitor intended to monitor patients' fluid balance in hospitals and surgical centers. The company's focus in 2021 has been on the clinical evidence supporting the CM-1500 and preparing the next generation device (CM-1600) for submission to the FDA.
Zynex, Inc. develops, manufactures, markets and sells medical devices used for pain management and rehabilitation, as well as non-invasive fluid, sepsis and laser-based pulse oximetry monitoring systems for use in hospitals. The Companyâs devices are intended for pain management to reduce reliance on medications and provide rehabilitation and increased mobility through the utilization of non-invasive muscle stimulation, electromyography technology, interferential current, neuromuscular electrical stimulation and transcutaneous electrical nerve stimulation. The Companyâs products include Zynex Medical Products, which includes NexWave, NeuroMove, InWave, E-Wave and M-Wave; Private Labeled Supplies, which includes Electrodes and Batteries; Distributed Complementary, which includes Comfortrac/Saunders, JetStream/Pain Management Technologies, LSO Back Braces and Bracing, and Zynex Monitoring Solutions Products, which includes CM-1500, CM-1600, NiCO CO-Oximeter and HemeOx tHb Oximeter.
ZYNEX, INC. 
