Zynex, Inc. today announced the U.S. Food and Drug Administration (“FDA”) granted 510(k) clearance for sale in the U.S. for the CM-1500 Blood Volume Monitor.
Thomas Sandgaard, CEO said: “I am very excited to finally have obtained FDA clearance to sell our non-invasive Blood Volume Monitor in the U.S. The device is fully developed, has performed well in multiple clinical trials and can guide medical professionals in hospitals and surgical centers towards better fluid management during surgery and in recovery settings. Fluid management during and after surgery is one of the largest unmet needs in hospitals today.”