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CardiacAssist Inc. receives FDA 510(k) approval for TandemLung

March 17, 2016


Pittsburgh-based CardiacAssist Inc. said Tuesday it had received approval from the U.S. Food and Drug Administration for its TandemLung oxygenator.

“After our original TandemHeart pump was cleared for use with an oxygenator in 2011, our team immediately began working with experts in the field to understand how to reduce the complexity of cardiopulmonary bypass technology so that more patients could receive this potentially life-saving procedure,” CardiacAssist President and CEO John Marous said in a statement Tuesday. “The design of the TandemLung is a direct result of those efforts. This release represents our 6th new product clearance since September 2013, and we are proud to dedicate ourselves to improving the lives of patients by delivering innovative, easy-to-use devices for simplified life support.”

Paul J. Gough is digital producer at the Pittsburgh Business Times, and writes about energy and the environment. Contact him at or 412-208-3827. You can also follow him on Twitter.

Source: CardiacAssist Inc. receives FDA 510(k) approval for TandemLung – Pittsburgh Business Times

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