Some Source Plasma manufacturers have requested and received approval for simplified nomograms. The FDA supports this type of process change which potentially improves the …

2020年7月16日 · The increased number of automated plasma collection devices with varying capacities for tailoring each collection to the specific donor has resulted in the existence of …

2024年3月14日 · Based on the results of the non-clinical and clinical tests performed on the Rika Plasma Donation System utilizing the individualized nomogram, it is as safe and effective as …

1992年11月4日 · The increased number of automated plasma collection devices with varying capacities for tailoring each collection to the specific donor has resulted in the existence of …

The US plasma collection target volume has been guided by a standard weight-based FDA-issued nomogram (STAN) since 1992. In this research, large-scale US-based real-world data (RWD) …

2025年1月28日 · The newly cleared Adaptive Nomogram considers each donor’s individual characteristics in calculating the volume of plasma to collect, enabling an average 11.5% …

2025年1月29日 · The U.S. Food and Drug Administration (FDA) has approved 510 (k) clearance for Fresenius Kabi’s Adaptive Nomogram, a different algorithm to be included in the Aurora Xi …

2025年1月28日 · Fresenius Kabi, a leading provider of lifesaving medications and technologies, recently achieved a significant milestone by receiving FDA 510 (k) clearance for its innovative …

2025年1月29日 · The Adaptive Nomogram takes into account individual donor characteristics to calculate the optimal volume of plasma to collect, resulting in an average 11.5% increase in …

2025年1月28日 · The newly cleared Adaptive Nomogram considers each donor’s individual characteristics in calculating the volume of plasma to collect, enabling an average 11.5% …