Zynex receives FDA 510(k) clearance of CM-1600 monitor

Zynex announced that the FDA has granted 510(k) market clearance for the company’s CM-1600 blood and fluid volume monitoring device. 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.