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Medical Devices / Submissions and Approvals

FDA Clears Fresenius Kabi’s RBCx System

Feb. 20, 2019
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The FDA has granted 510(k) clearance to Fresenius Kabi’s Fenwal Amicus red blood cell exchange (RBCx) system.

The product — which has been cleared in Europe and the U.S. for plasma exchange and the collection of platelets and mononuclear cells — is able to perform the automated removal of a patient’s red blood cells and replace them with prescribed replacement fluid.

The device enables physicians to select from three procedures for the transfusion management of sickle cell disease in children and adults.

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