Wednesday, June 21, 2023
Zynex, Inc a renowned medical technology company specializing in non-invasive medical devices for pain management, rehabilitation, and patient monitoring, has announced that the FDA (Food and Drug Administration) has granted 510(k) market clearance for their CM-1600 blood and fluid volume monitoring device.
Zynex's CEO, Thomas Sandgaard, expressed his satisfaction with the FDA's clearance of their second-generation monitor, which utilizes non-invasive and wireless technology. The CM-1600 is designed to enhance patient outcomes by improving fluid management in hospital settings. By tracking multiple physiological changes relative to blood and fluid variations, the device aims to provide valuable insights. Sandgaard also mentioned their commitment to gathering additional data through clinical trials, with the goal of generating meaningful revenue in the monitoring division, which already operates profitably within Zynex.
Apart from the CM-1600, Zynex's hospital monitoring product division has three other products in the pipeline. These include NiCO™, a laser-based pulse oximeter; a monitor for early detection of sepsis; and HemeOx™, a non-invasive, laser-based monitor for total hemoglobin levels. While the monitoring division is currently pre-revenue, they anticipate submitting an FDA application for the laser-based pulse oximeter in the fourth quarter of this year.