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Fenwal Receives FDA Clearance for Wireless Data Export on ALYX Blood-Collection System

December 16, 2010 By Bio-Medicine.Org

LAKE ZURICH, Ill., Dec. 16, 2010 /PRNewswire/ — Fenwal, Inc., a
global medical technology company focused on improving blood
collection, separation, safety and availability, announced today
the U.S. Food and Drug Administration has granted Fenwal 510(k)
clearance to market its ALYX™ component collection system
with new wireless data export capabilities.

The ALYX system is a mobile blood component collection device
used primarily to collect red blood cells.  The system can
collect two units of red cells from a single donor in less than 30
minutes.  

The addition of wireless data export allows blood collection
professionals to electronically access detailed information about
donation procedures on mobile and fixed-site blood drives.
 These data can then be used to track and improve blood center
performance and enhance the donation experience for donors and
collectors.

When accompanied by the Fenwal data exchange system, scheduled
for release in the first half of 2011, data export will allow
centers to create customized reports with procedure and other data
from the ALYX system.  Blood centers can use these data to
identify training opportunities designed to enhance operator and
system performance.

Fenwal is unique in offering data export capabilities designed
for open-source compatibility with blood and plasma center
information systems.  Earlier this year Fenwal received FDA
clearance for wireless data export on the Fenwal AMICUS™
system, which is used to collect platelets, and the Fenwal
AUTOPHERESIS-C™ system, which collects plasma.  

“In providing data export for apheresis systems, our objective
is to help the professionals who collect blood and plasma to
improve how they work, optimizing their productivity and offering a
positive experience for donors,” said William H. Cork, chief
technology officer for Fenwal.  “Blood collectors are vital to
the nation’s blood supply and

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SOURCE

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