Sysmex America, Inc. Announces FDA Clearance of XN-Series Hematology Analyzers
LINCOLNSHIRE, IL--(Marketwire - October 23, 2012) - Sysmex America, Inc. and Sysmex Corporation, Kobe, Japan, today announce the United States Food and Drug Administration's (FDA) clearance of the Sysmex® XN-Series Hematology Analyzers. Sysmex previously received a Medical Device License for the analyzers from Health Canada. The XN-Series enables laboratories of any size to implement advanced clinical parameters, including an all-new fluorescent platelet channel for Immature Platelet Fraction (IPF) to aid in the differential diagnosis of thrombocytopenia. The scalable, series-wide compact design delivers a smaller footprint that optimizes speed and functionality and provides automation benefits across the entire XN-Series. The series includes the Sysmex XN-1000™, Sysmex XN-2000™, and Sysmex XN-3000™. The Sysmex XN-9000™, coupled with tube sorting and archiving, HbA1c automation and powered by Intelligent Automation from the Sysmex WAM™, carries the Lavender Top Management® capabilities introduced by Sysmex for the management of more than 90% of most lab's lavender top tubes. The hematology analyzers are available for sale in the U.S., Canada and Latin America. Sysmex is a global leader in clinical laboratory systemization and solutions, including clinical diagnostics, automation and information systems and services hospitals and healthcare networks, reference laboratories and physicians offices worldwide.
"The FDA clearance of the Sysmex XN-Series Hematology Analyzers puts Sysmex at the forefront of 'accountable care' by enabling clinical laboratories to contribute to the overall efficiency and productivity of their hospitals. Advanced clinical parameters, now available to virtually any clinical laboratory regardless of throughput, have potential to impact treatment guidelines, care pathways, and patient flow. This has broad implications on the healthcare industry, especially considering much of a patient's medical record is comprised of laboratory results," said John Kershaw, President & CEO, Sysmex America, Inc.
The design intent for the Sysmex XN-Series Hematology Analyzers is to enable clinical laboratories to withstand future medical technologists shortages; and the ability to keep up with workload demands and testing complexity that may accompany an aging population. This breakthrough concept known as Silent Design® provides a simplified system of operation and user interface based on careful study of laboratory processes, the relationship between the operator and the analyzer and how people work. "The human-centered approach of Silent Design, upon which the XN-Series analyzers are built, are truly representative of how Sysmex is resolving current day issues in the clinical laboratory while helping to reshape the healthcare landscape of tomorrow," added Kershaw.
Sysmex Corporation, Kobe, Japan, was awarded the Good Design Gold Award in October 2011 from Japan's Ministry of Economy, Trade and Industry for its in vitro diagnostic system employing the company's new Silent Design® concept.
About Sysmex XN-Series Hematology Analyzers
The Sysmex XN-Series Hematology Analyzers enable laboratories of any size to implement advanced clinical and operational capabilities. All configurations provide advanced clinical parameters, including NRBCs with every CBC, immature granulocytes with every Diff, RET-He within the reticulocyte profile and an all-new fluorescent platelet channel for IPF to aid in the differential diagnosis of thrombocytopenia. The series-wide compact design delivers a smaller footprint for increased physical productivity. Smaller reagent sizes and concentrated reagents simplify consumable inventory management. Scalable options exist for auto-validation approaches -- from onboard decision rules to Sysmex WAM™ middleware. The XN-Series is also supported by the Sysmex Peak Performance Program, a rich and comprehensive set of systems and resources that work together to ensure the laboratory's long-term success.
About Silent Design®
Sysmex Corporation, Kobe, Japan, was awarded the Good Design Gold Award in October 2011 from Japan's Ministry of Economy, Trade and Industry for its in vitro diagnostic system employing the company's new Silent Design® concept. The award is given to 12 Good Design Award recipients whose high-quality designs are deemed particularly outstanding in helping to resolve current-day issues. The Good Design Award is a Japanese comprehensive design evaluation and commendation system operated since 1998 by the Japan Institute of Design Promotion (JDP). The system has its origins in the "Good Design Selection System" (known as the "G-Mark System") instituted by the Ministry of International Trade and Industry (now, the Ministry of Economy, Trade and Industry) of Japan in 1957. The judging panel for the Good Design Award includes a 70-member committee made up of designers, architects, editors, and other specialists working at the cutting edge of design.
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 40 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 www.sysmex.com/us.