Mediware’s HCLL System Receives FDA Clearance for Integrating Complex Laboratory Instrumentation
Mediware Information Systems, Inc. an acknowledged leader in clinical information and patient safety software management solutions, announced that it has received US Food and Drug Administration (FDA) 510(k) clearance to market the latest enhancement to its next-generation transfusion management system, Hemocare LifeLine (HCLL(TM)), in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act.
The new enhancement supports the integration of complex laboratory testing equipment allowing for full-automation of the complex workflows within the hospital blood bank.
Commenting on the FDA 510(k) clearance, George Barry, Mediware’s CEO said, “This latest enhancement to HCLL sets a new standard for workflow efficiency and safety within the hospital laboratory. Laboratory test results can now flow seamlessly thereby eliminating errors, saving time in processing, and supporting the overall objective of enhancing patient safety.”
About HCLL
HCLL, the next-generation transfusion management system, is designed to manage blood products administered to patients at hospitals and centralized transfusion service facilities. HCLL greatly expands on the functions and features offered by traditional legacy transfusion systems while supporting the main objective of enhancing patient safety within complex hospital environments. Enhanced management features and functions of HCLL include:
- Advanced capabilities for centralized transfusion services, electronic and remote cross-matching, and quality control management;
- Ability to scale transfusion services for a single hospital as well as for large multi-site/multi-facility hospital networks; complete integration with hospital and laboratory information systems; configurations in Client/Server or Thin-Client Web-enabled platforms; and full support of industry bar code standards and enhanced process flow and control.
About Mediware Information Systems, Inc.
Mediware provides clinical information systems for hospitals and integrated healthcare delivery systems. Its products include HEMOCARE LifeLine(TM), Hemocare(R), LifeLine(R), LifeTrak(R), and HCLL(TM) (blood bank), WORx(R), MediMAR(TM), MediCOE(TM), Pharmakon(R), and Digimedics(TM) (pharmacy), Surgiware(TM), Perioperative Solutions(TM) (operating room), as well as the JAC Stock Control System (pharmacy) in the United Kingdom. Mediware has over 1,100 systems installed in the U.S., Canada, the U.K., and elsewhere. www.mediware.com
Certain statements in this press release may constitute “forward-looking”‘ statements within the meaning of the Private Securities Litigation Reform Act of 1995, as the same may be amended from time to time (the “Act”‘) and in releases made by the SEC from time to time. Such forward-looking statements are not based on historical facts and involve known and unknown risks, uncertainties and other factors disclosed in the Company’s Annual Report on Form 10-K for the year ended June 30, 2003, which may cause the actual results of the Company to be materially different from any future results expressed or implied by such forward-looking statements. The Company disclaims any obligation to update its forward-looking statements.
