Healthcare Industry News:  RT Technology 

Diagnostics FDA

 News Release - May 16, 2006

Sysmex Receives FDA Clearance for New Hematology Analyzer

Smaller Clinical Laboratories and Physicians Offices to Benefit

MUNDELEIN, Ill., May 16 (HSMN NewsFeed) -- Sysmex America, Inc. announced today that the Sysmex XS-1000i(TM) Automated Hematology Analyzer has been cleared by the United States Food and Drug Administration (FDA) for use in clinical laboratories and physician offices. This new analyzer, which is available both with and without an auto sampler, utilizes fluorescent flow cytometry and advanced cell-counting methods to deliver rapid, reliable tests results which are essential in advanced patient diagnosis and therapeutic monitoring. This analyzer represents the completion of the Sysmex X-Series family of hematology instruments.

The Sysmex XS-1000i provides medical laboratory personnel with discrete hematology testing options for CBC and CBC with 5-part differential, utilizing fluorescent flow cytometry for WBC analysis and hydrodynamic sheath flow technology for measurement of red cell and platelet cell counting. Sampling is done in a "closed tube" environment assuring operator safety. The XS-1000i offers 21 testing parameters. As with all Sysmex analyzers, the system utilizes only non-hazardous reagent systems.

"With FDA's clearance of the XS-1000i, Sysmex is truly in a unique position of being able to offer the same state of the aRT Technology platform to any size laboratory. Whether it is a small laboratory or a larger institution, we are the only vendor that can offer them access to the same powerful diagnostic capabilities," said John Kershaw, President, Sysmex America, Inc.

About Sysmex America, Inc.

Sysmex America, Inc., the U.S. headquarters of Sysmex Corporation (Kobe, Japan), is a world leader in clinical laboratory systemization and solutions, including clinical diagnostics, automation and information systems. Serving customers for over 35 years, Sysmex focuses on extending the boundaries of diagnostic science while providing the management information tools that make a real difference in clinical and operational results for people worldwide. For more information about Sysmex, please visit http://www.sysmex.com/usa .



Source: Sysmex

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