Medtronic, Inc. Gets FDA Clearance for Oxygenation System

Medical device maker Medtronic Inc. said Tuesday it received U.S. clearance for a new artificial lung system that acts as a patient's lung who are undergoing open heart surgery. The Food and Drug Administration cleared the company's Affinity Fusion oxygenation system, which is designed to oxygenate and remove carbon dioxide from the blood. Each year about 1 million patients worldwide undergo cardiopulmonary bypass surgery, a procedure in which the heart and lungs are temporarily stopped, according to Medtronic.

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