Zynex—a medical device company for pain management, rehabilitation, and patient monitoring—has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its next generation fluid monitoring system, the CM-1600.
“I am thrilled to announce that we have submitted a 510(k) premarket notification to the FDA for our CM-1600. We have worked diligently at adding key enhancements to our FDA-cleared CM-1500 Fluid Monitoring System, including wireless connectivity to the non-invasive wrist wearable,” says Thomas Sandgaard, CEO. “This 510(k) submission is an important step in the evolution of our fluid monitoring system, which we believe will become a vital tool to ensure optimal fluid management and quality care for patients at risk for hemorrhagic events.”
The Zynex Fluid Monitoring System (CM-1500) is a 100% non-invasive solution for monitoring fluid changes throughout patient care environments. Patient fluid status is determined using an algorithm that combines the trends of several physiological parameters to generate a single Relative Index (RI) value, allowing for fast interpretation of changes in fluid volume.
“We are pleased to bring a meaningful treatment improvement to market through the submission of the CM-1600 to the FDA for 510(k) clearance,” says Donald Gregg, Vice President, Zynex Monitoring Solutions. “The improved fluid and blood volume monitor will provide more accurate patient observance before, during, and after surgical procedures. We look forward to working closely with the FDA throughout the submission and clearance process to bring this next generation, first of its kind technology to the market.”