Edwards Lifesciences (NYSE:EW) said today that the FDA granted 510(K) clearance for its ClearSight patient monitoring system.
The non-invasive device is designed to provide blood volume and blood flow data for patients "at moderate or high risk of post-surgical complications, in whom invasive monitoring would not be used," according to a press release.
"The ClearSight system is the most advanced noninvasive monitor of its kind. This important development in the field of critical care medicine builds on Edwards’ 40 years of experience in providing clinicians with tools to make more informed decisions that can advance patient care by helping to reduce complications, shorten hospital stays and lower associated costs," critical care and vascular vice president Carlyn Solomon said in prepared remarks.
Edwards said the ClearSight device has also been granted CE Mark approval in the European Union.
"Proper intraoperative management of moderate and high–risk surgery patients is critical to help reduce the risk of post–surgical complications," Dr. Julie Thacker of the Duke University Hospital said in a statement. "Studies have indicated that patient outcomes are improved through monitoring and management of vital hemodynamic information through hemodynamic optimization protocols."
