Fresenius Kabi Reports the Reguatory Submission to the US FDA for the Aurora Xi Plasmapheresis System Software Version 2.0 with New Nomogram
Shots:
- Fresenius Kabi has submitted a 510(k) to the US FDA for Aurora Xi Plasmapheresis System software 2.0, containing an adaptive nomogram that employs donor’s features to target a collection volume. It is cleared in the US for plasma collection using Standard and Optimized nomogram algorithms to determine collection volume
- The submission was based on a trial assessing Aurora Xi Software 2.0 vs existing nomogram, with over 52,400 procedures completed at Takeda's BioLife Plasma donation centers
- The Aurora Xi Plasmapheresis System includes the Aurora Xi instrument and Plasmacell Xi disposable set for automated plasma collection, separating plasma from blood and returning cellular components to the donor
Ref: Fresenius | Image: Fresenius
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
