Zynex Inc., a medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced that the FDA has granted 510(k) market clearance for the company’s CM-1600 blood and fluid volume monitoring device.
Further Reading: Zynex Submits FDA Application for Fluid Monitoring System
“I am pleased to announce FDA clearance for our second-generation blood and fluid volume monitor,” says Thomas Sandgaard, founder and CEO of Zynex. “Our non-invasive and wireless technology is targeted to improve patient outcomes with better fluid management in hospital settings. The device is based on tracking multiple physiological changes relative to blood and fluid changes in the patient. We will continue to collect additional data in clinical trials going forward and I am eager for the monitoring division to eventually add meaningful revenue to Zynex’s already profitable pain management division.”
Building on the momentum of the CM-1600 monitor, Zynex’s division for hospital monitoring products has three additional products in the pipeline: a laser-based pulse oximeter, NiCO; a monitor for early detection of sepsis; and a non-invasive, laser-based monitor of total hemoglobin levels, HemeOx. The monitoring division is pre-revenue and expects to submit an application to the FDA for its laser-based pulse oximeter in the fourth quarter of this year.
About Zynex Inc.
Zynex, founded in 1996, develops, manufactures, markets, and sells medical devices used for pain management and rehabilitation as well as non-invasive fluid, sepsis, and laser-based pulse oximetry monitoring systems for use in hospitals. For additional information, visit www.zynex.com.