LivaNova’s Essenz ILBM receives FDA 510k clearance, CE Mark

LivaNova PLC announced it received U.S. Food and Drug Administration 510(k) clearance and CE Mark for its Essenz In-Line Blood Monitor, which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass procedures. The ILBM is integrated into LivaNova’s next-generation CPB platform, the Essenz Perfusion System, which allows perfusionists to access and manage reliable blood parameters directly from the system’s cockpit, without the need for additional monitors or holders.