Zynex, Inc. Announces First Enrollments in Apheresis Donation Clinical Trial with Second Generation Fluid Monitoring System
August 15, 2022 at 09:15 am EDT
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Zynex, Inc. announced it has started enrollments in an ongoing apheresis clinical trial with its second-generation fluid monitoring system, the CM-1600. The study monitors subjects during an apheresis procedure with the predicate device, the CM-1500, and now also the CM-1600, to refine the system's patented Relative Index in a wide array of patient circumstances. To date, 53 subjects have been enrolled in the study.
Zynex's second generation blood and fluid monitoring device has been introduced to the study to evaluate its sensitivity and accuracy in the same environment. The CM-1500 was cleared by the FDA in February of 2020 while the CM-1600 is still awaiting FDA clearance. The study is expected to complete enrollments in the fourth quarter of 2022.
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. 
