Healthcare Industry News:  hematology analyzer 

Diagnostics FDA

 News Release - December 11, 2007

Sysmex America Receives FDA Clearance for XE-5000(TM) Hematology Analyzer

MUNDELEIN, Ill., Dec. 11 (HSMN NewsFeed) -- Sysmex America, Inc. today announced that its Sysmex XE-5000 Automated hematology analyzer has been cleared by the United States Food and Drug Administration (FDA) for sale in the U.S. The XE-5000 represents an enhanced, best-in-class, high throughput analyzer that provides 31 whole blood reportable parameters including advanced clinical parameters and a body fluid specific mode. The Sysmex XE-5000 will be available in the United States, in Latin America and in Canada beginning in December 2007.

Like its other X-Series counterparts, the XE-5000 uses Sysmex's patented fluorescent flow cytometry technology, providing both routine hematology testing and abnormal cell flagging within a single sample run. The body fluid specific mode is the first of its kind in the industry with reportable body fluid differential parameters for all common body fluids (CSF, Serous and Synovial). Complete information within a single analysis reduces manual intervention and the errors inherent in manual counts. Hospital or university laboratories and clinics with renal, oncology and acute care patient populations will benefit from the XE-5000.

"The XE-5000 is Sysmex's next step in aiding our nation's larger-volume clinical laboratories in their efforts to become increasingly efficient with their staffing and financial resources without sacrificing quality or accuracy. With the proven reliability of Sysmex analyzers, clinical laboratories have the assurance of greater uptime," said John Kershaw, president, Sysmex America, Inc.

As with other Sysmex product lines, the XE-5000's performance can be remotely monitored by SNCS(TM) (Sysmex Network Communications Systems). SNCS continuously collects and monitors hundreds of real-time performance codes from Sysmex analyzers. This feature generates a technical review of any potential critical instrument errors that may be occurring behind the scenes. The connectivity allows Sysmex technicians to proactively contact the customer and to help correct any issues prior to system or part failures.

Sysmex hematology analyzers have been ranked as the industry's best in reliability and performance for eight consecutive years by the IMV ServiceTrak(TM) survey. IMV ServiceTrak(TM), conducted by an independent research company that analyzes science-based instrument industries, surveyed more than 1,600 randomly chosen clinical laboratory health care professionals from varying hospital sizes across the country.

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 America

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