Zynex 的 CM-1600 血液和体液容量监测仪获得 FDA 批准

Zynex Medical has received 510(k) clearance from the Food and Drug Administration (FDA) for its CM-1600 Blood and Fluid Volume Monitor.

Zynex’s non-invasive and wireless technology is designed 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, according to Thomas Sandgaard, Founder and CEO of Zynex.

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.