Haemonetics (NYSE:HAE) said today it won FDA 510(k) clearance for its NexSys PCS plasmapheresis system designed for collecting blood plasma.
The NexSys PCS includes bi-directional connectivity to the Braintree, Mass.-based company’s NexLynk DMS donor management system, and allows for automated collection procedure programming and automated end of procedure documentation.
“NexSys PCS is designed to increase productivity and improve quality and compliance in plasma collection centers. Each of these benefits is noteworthy and when combined we believe will unlock meaningful value for our customers,” CEO Christopher Simon said in a press release.
Haemonetics said it plans to immediately begin a limited production of the NexSys PCS systems while pursuing other regulatory clearances for product enhancements.
In May, Haemonetics released 4th quarter and full 2017 fiscal year earnings results that beat expectations on Wall Street.
