XN-Series of Hematology Analyzers Receive FDA Clearance

Sysmex America, Inc. and Sysmex Corporation, Kobe, Japan, announced today that the Sysmex® XN-Series Hematology Analyzers have received clearance from the United States Food and Drug Administration (FDA). Sysmex have previously received a Medical Device License for the analyzers from Health Canada. The hematology analyzers are available for sale in the U.S.A, Canada and Latin America.

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 XN-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 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.