The approval allows Zynex to market CM-1500, a blood monitoring system aimed at helping doctors monitor various patient parameters.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Cardiac Monitor, Model 1500 (CM-1500), a cardiac monitoring system intended to provide data to clinicians, doctors, and post-operative care providers.
The system could be particularly beneficial for anesthesiologists and surgeons who seek accurate diagnostic tools and continuous data monitoring systems.
The cardiac monitoring system, developed by Zynex Medical, simultaneously monitors various parameters of a patient’s body, including bioelectrical impedance, electrocardiogram, heart rate, ECG amplitude, PPG amplitude, skin temperature, and skin humidity.
The system then calculates a relative index value as a combination of all the parameter that is represented by a single number.
The methods and processes used to monitor and filter the physiological parameters, through the use of the weighted summation algorithm, produce the singular relative index score that is entirely unique to this blood monitoring system.
CM-1500 will join a lineup of non-invasive produced by Zynex for pain management, stroke rehabilitation, cardiac monitoring, and neurological diagnostics.
"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,” Zynex CEO Thomas Sandgaard said in a statement. “Fluid management during and after surgery is one of the largest un-met needs in hospitals today.”