Fresenius Kabi seeks FDA approval for innovative plasmapheresis software
Fresenius Kabi, a global healthcare company, has filed a 510(k) notification with the U.S. Food and Drug Administration (FDA) for its Aurora Xi Plasmapheresis System software version 2.0. The updated software introduces a proprietary, adaptive nomogram that personalizes plasma collection based on individual donor characteristics, a move set to revolutionize source plasma collection. The Aurora […]