FDA clears Edwards' clinical monitoring platform

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The FDA has given 510(k) clearance to Edwards Lifesciences for its new EV1000 clinical monitoring platform.

The EV1000 clinical platform is designed to aid in the decision-making process in both the OR and intensive care unit by providing a touch-screen monitor that displays a patient's physiologic status, according to the Irvine, Calif.-based developer of heart valves and hemodynamic monitoring.