Zynex Inc., a medical technology company specializing in noninvasive medical devices for pain management, stroke rehabilitation, cardiac and neurological diagnostics, and compound pharmacy, has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance of the company's new CM1500 monitoring device.
According to the company, the CM1500 is capable of monitoring a patient's fluid levels, including blood loss, during surgery and in recovery.
Thomas Sandgaard, CEO if Zynex, said: "We are excited to have reached the point of applying for FDA clearance for our revolutionary device that will enable surgical personnel to non-invasively monitor blood loss in real time. We have begun placing initial production units in hospitals for field testing and validation. Undetected blood loss continues to be a significant risk during surgery and recovery, and current approaches are either too invasive or lacking precision and early predictive capability for blood loss and intervention. The CM1500 will reduce the risk of blood loss going undetected."
Based in Lone Tree, Colo., and founded in 1996, Zynex makes electrotherapy medical devices used for pain management and rehabilitation; and the company's proprietary NeuroMove device designed to help recovery of stroke and spinal cord injury patients.