US FDA Approves Zynex's CM-1600 Monitor for Improved Blood & Fluid Management

Zynex, Inc., an innovative medical technology company specialising in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, has announced that the FDA has granted 510(k) market clearance for the company's CM-1600 blood and fluid volume monitoring device. "I am pleased to announce FDA clearance for our second-generation blood and fluid volume monitor," said Zynex's founder and CEO, Thomas Sandgaard. "Our non-invasive, wireless technology aims to improve patient outcomes in hospital settings through better fluid management."

The device works by monitoring multiple physiological changes in the patient's blood and fluid levels. We will continue to collect data in clinical trials in the future, and I am hopeful that the monitoring division will eventually contribute meaningful revenue to Zynex's already profitable pain management division." Three more products are in the works for Zynex's hospital monitoring division: a laser-based pulse oximeter, NiCO; a monitor for early detection of sepsis; and a non-invasive, laser-based monitor of total haemoglobin levels, HemeOx.

The monitoring division is pre-revenue and plans to submit an application to the FDA in the fourth quarter of this year for its laser-based pulse oximeter. Zynex, which was founded in 1996, develops, manufactures, markets, and sells medical devices for pain management and rehabilitation, as well as non-invasive fluid, sepsis, and laser-based pulse oximetry monitoring systems for hospital use.