Fenwal Inc. said it landed 510(k) clearance from the FDA for a new version of software for its Alyx blood collection system.
The new Alyx software also supports remote procedure setup and paperless documentation when used with the Fenwal DXT Relay data exchange software and a blood center’s blood establishment computer system, according to a press release.
“Alyx is a mobile, easy-to-use blood component collection system. With this latest clearance, Alyx can now be used to collect up to 825mL of plasma from a single donor, helping blood centers meet the growing hospital demand for plasma. This is the latest of several regulatory clearances for Fenwal products since becoming part of Fresenius Kabi and each is an example of our commitment to advance transfusion medicine,” Fresenius Kabi North America medical devices division president Dean Gregory said in prepared remarks.