FDA Clears Haemonetics’ New Plasmapheresis System

Haemonetics Corporation has received FDA 510(k) clearance for its NexSys PCS plasmapheresis system. The NexSys PCS includes bi-directional connectivity to Haemonetics’ donor management system, NexLynk DMS, and builds on Haemonetics’ industry leading position with a design inspired by extensive user research.
 
“NexSys PCS is designed to increase productivity and improve quality and compliance in plasma collection centers,” said Christopher Simon, CEO of Haemonetics. “Each of these benefits is noteworthy and when combined we believe will unlock meaningful value for our customers.”
 
The open architecture of NexSys PCS facilitates bi-directional connectivity to donor management systems enabling automated collection procedure programming and automated end of procedure documentation. The simple guided operation, large intuitive touch screen, and on-screen troubleshooting assistance on NexSys PCS are designed to improve plasma center efficiencies resulting in reduced total time for donors in the center and improved collection capacity per plasma center. 
 
As previously communicated, Haemonetics plans to immediately begin limited production of NexSys PCS devices and intends to pursue further regulatory clearances for additional enhancements to the overall product offering.
 
NexSys PCS and NexLynk DMS were previously referred to as PCS 300 and NexGen DMS.