Jan Hartmann: NexSys Plasma Collection System Receives FDA Clearance
Jan Hartmann, Chief Medical Officer at Haemonetics, reposted from Haemonetics on LinkedIn:
”Exciting Next Step in Plasma Collection Innovation
Happy to share that the NexSys PCS Plasma Collection System with Persona PLUS technology has received FDA 510(k) clearance.
This milestone reflects an extraordinary cross‑functional effort.
Our submission was supported by a large, rigorous randomized controlled clinical trial involving nearly 3,000 plasma donors and more than 30,000 plasma collection procedures.
At its core, this work put donor safety first—carefully studying outcomes while advancing our personalized approach to plasma collection.
We saw increases in average plasma volume per donation, with no negative impact to safety, helping strengthen source plasma availability for life‑changing plasma‑derived medicinal products.
With global demand for these therapies continuing to grow, innovation that responsibly improves efficiency and yield matters more than ever.
Grateful to everyone who contributed to this important step forward—for donors, plasma collectors, and ultimately the patients who depend on these therapies.”
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