The study will record changes in CM-1500’s patented Relative Index during apheresis blood donation procedures
Medical technology firm Zynex has commenced recruitment of patients in an apheresis blood donation clinical study for its fluid monitoring system called CM-1500.
The clinical trial has been designed to further characterise the performance of the company’s fluid monitoring system.
Conducted at Vitalant Research Institute, the study will record changes in CM-1500’s patented Relative Index during apheresis blood donation procedures.
Vitalant Research Institute is the research arm of Vitalant, an independent and nonprofit blood services provider.
Zynex Monitoring Solutions vice president Donald Gregg said: “We are excited to continue innovating the portfolio of clinical evidence to support the performance of our non-invasive fluid monitoring technology.
“We believe this technology is fulfilling an unmet need to manage fluid and blood loss across the clinical care continuum.”
The CM-1500 is a non-invasive monitor designed for the monitoring of patients’ fluid balance in hospitals and surgical centres.
In February 2020, the company secured clearance from the US Food and Drug Administration (FDA) for the fluid monitoring system.
Zynex stated that its focus has been on the clinical evidence supporting the CM-1500 last year and preparing the next generation device called CM-1600 for submission to the FDA.
Zynex CEO, chairman and founder Thomas Sandgaard said: “We’re excited to participate in more studies, like this one, to validate the Relative Index and our technology. We look forward to more research throughout 2022 as we continue innovating our technology for the CM-1600.”
Last December, Zynex agreed to acquire laser-based, noninvasive patient monitoring technology provider Kestrel Labs in a deal valued at around $31m.
Established in 1996, Zynex is engaged in the manufacturing and marketing of electrotherapy medical devices for pain management and rehabilitation.
The company is also involved in the development of noninvasive patient fluid, pulse oximetry and sepsis monitoring systems.