Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency
Shots:
- The US FDA has granted 510(k) clearance to Adaptive Nomogram algorithm in the Aurora Xi Plasmapheresis System to improve plasma collection efficiency
- Clearance was based on a trial of Adaptive Nomogram in Aurora Xi Software Version 2.0 vs the existing Optimized Nomogram involving >52,400 procedures that met its 1EP, depicting increased plasma volume by 88mL (11.5%, w/o anticoagulant) & extended procedure time by 3m 37s (9.7%)
- The Adaptive Nomogram with Aurora Xi has the ability to set collection parameters based on donor’s characteristics and collect an average of 11.5% more plasma per donation for developing plasma derived therapies. It will be available in Takeda’s BioLife plasma donation centers across the US
Ref: Fresenius Kabi | Image: Fresenius Kabi
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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.
