Edwards HemoSphere Hemodynamic Monitoring System Cleared by FDA

Edwards Lifesciences won FDA clearance for its HemoSphere hemodynamics monitoring system. It works with the Swan-Ganz pulmonary artery catheters that can provide flow, pressure and global indicator of oxygen saturation (CCO, RVEF, RVEDV, SVO2), and the Edwards oximetry central venous catheter that in addition to those can continuously monitor central venous oxygen saturation (ScvO2).

A touchscreen monitor is used to control the device, which also displays all the readouts. There’s a bunch of choices available as to what to display, depending on the patient being taken care of. There’s live “cockpit style,” tabular, and graph displays that provide their own unique views that can also be mixed together on one screen.

The system has already been approved for sale in Europe, Japan, Australia, and New Zealand.