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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