Fenwal Inc, has announced today clearance from the U.S. Food and Drug Administration (FDA) to market the Fenwal Amicus® separator and Fenwal DXTTM Relay productivity software for paperless documentation and remote procedure set-up. Used together the products have been designed to help blood collectors improve efficiency and meet regulatory compliance.
Paperless Documentation and Remote Procedure Set-Up Improves Blood Center Efficiency
The Amicus® separator is a medical device used to collect platelets, red cells, and plasma, as well as mononuclear cells for therapeutic applications. The Fenwal DXTTM Relay software provides blood center professionals with easy-to-read, on-demand reports that aggregate donor and procedure data from Fenwal apheresis systems at multiple locations. Reports track specific performance indicators to help identify opportunities for improvement and data.
The FDA clearance granted today allows the Amicus® separator to be used with the Fenwal DXTTM Relay software, to provide paperless documentation and remote procedure setup. It is the first Fenwal apheresis device to receive this clearance, although similar programs are under development for the company’s other apheresis systems.
“The Amicus® separator with DXTTM Relay software provides our customers with a flexible and affordable solution that supports paperless documentation and strengthens data-driven decision making,” said William H. Cork, chief technology officer for Fenwal. “This is the newest product introduction in a series of innovations designed to help blood centers improve productivity, while making it easier to maintain regulatory compliance and manage blood inventories according to patient needs and donor qualifications.”
Company websiteFenwal Blood Technologies