FDA clears Edwards' clinical monitoring platform

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.

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