Tuesday, December 21, 2021
Zynex, Inc., an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation and patient monitoring, today reported it has started enrollments in a hemodialysis clinical trial with its fluid monitoring system, CM-1500. The study, conducted at DaVita Clinical Research clinics, is aimed at further characterizing changes in the device's patented Relative Index during hemodialysis procedures where a large volume of fluid is removed from patients. 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.
"Engaging in these trials will not only refine our devices and technology but will also push the monitoring division forward to better serve patients across the world. We're excited to take this next step in innovating the clinical value that our technology provides hospitals and surgical centers", said Thomas Sandgaard, CEO, Chairman and Founder.
Zynex Monitoring Solutions expects to initially target operating rooms and surgeries that typically display substantial blood loss, as well as recovery rooms and intensive care units where internal bleedings are more common and difficult to detect until serious complications occur.
Donald Gregg, VP of Zynex Monitoring Solutions said: "Investing in clinical evidence is critically important to clearly articulate how our device performs in multiple care settings, and the hemodialysis population is of particular interest due to the controlled setting and known volume removed from patients on a regular basis."
The study is expected to complete enrollments in the first quarter of 2022.