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.”
Stay updated with Hemostasis Today.
-
May 27, 2026, 09:58Omid Seidizadeh: Take The EAHAD Survey on Access to Diagnosis and Treatment for VWD Europe
-
May 27, 2026, 09:51Richard Benjamin: RedeS Phase III Trial Reaches Major Milestone in Advancing Pathogen-Reduced RBCs for Transfusion
-
May 27, 2026, 04:47Daniel Torrent: The Overlooked Epidemic of Post-Thrombotic Syndrome
-
May 27, 2026, 04:45Graziella Pompei: Is Aspirin Still a Valid Alternative to Clopidogrel in PCI with DES Implantation?
-
May 27, 2026, 04:40Kausik Ray: Phase 1 Trial Highlights Anti-Inflammatory Effects of Ruvonoflast
-
May 27, 2026, 04:29Francisco Chacón-Lozsán: High-Sensitivity Troponin and the Evolving Management of NSTEMI
-
May 27, 2026, 04:14Michael R. Jaff: HI-PEITHO Trial and NEWS Score Insights on Advances for Intermediate-Risk Pulmonary Embolism
-
May 26, 2026, 16:45Ashley George: Take the Leap for Thrombosis UK
-
May 26, 2026, 16:40Hamed Helisaz: Machine Learning for Detecting Missing Heart Medications