DENVER, Oct. 18 /PRNewswire-FirstCall/ -- Global Med Technologies(R), Inc. (OTC Bulletin Board: GLOB), an international e-Health, medical information technology company, announced today that its Wyndgate Technologies(R) division ("Wyndgate") has submitted its ElDorado Donor(TM) software for a 510(k) clearance by the U.S. Food and Drug Administration (FDA). ElDorado Donor is currently not for sale in the U.S., pending 510(k) clearance by the FDA.
ElDorado Donor is intended as a comprehensive blood management software application designed to provide for the information system needs of a blood bank and donor centers. The software is designed to manage, automate, and control activities associated with donors, donor collections, testing, manufacturing, inventory, and distribution. ElDorado Donor was developed with scalability in mind and is designed to manage the system needs of diverse facilities, from small hospital blood banks to community blood centers, to regional and national centers, both domestically and internationally.
Utilizing an integrated modular configuration, ElDorado Donor is intended to offer functionality with flexibility to tailor features within the system to a facility's specific needs and to support process control from collection to distribution. The software is designed for ease-of-use and includes drop down lists and easy access find forms. Wyndgate's At-a-Glance(TM) bars are to provide a visual indication of the presence of relevant information that can be viewed and provide quick and easy access to the information. ElDorado Donor is designed to support the upcoming industry standard for labeling (ISBT128), as well as the ABC Codabar blood product labeling standard.
ElDorado Donor is to include safety checks for blood components, blood products, and other related supply items. These safety checks are to be performed throughout the system as part of the normal processing of donors, blood components, and other blood products. ElDorado Donor is to provide extensive manufacturing controls that can be tailored for a specific site depending on its processes.
The blood management software has been designed with guidance from Wyndgate's technology workgroup, comprised of leading industry representatives from around the world. Throughout the ElDorado Donor development process, the work group's contributions assisted the Company in delivering a feature-rich and user-friendly solution.
Miklos Csore, Vice President of Research and Development, commented, "Global Med Technologies and Wyndgate Technologies are delighted that ElDorado Donor has been submitted for FDA 510(k) clearance. Wyndgate's management and staff have strived to provide an innovative quality healthcare solution, which will assist our customers in meeting their business and regulatory needs. We wish to thank our technology work group, who has been invaluable throughout this process." Mr. Csore continued, "We look forward to the response from FDA regarding clearance for ElDorado Donor."
About Global Med Technologies, Inc.
Global Med Technologies(R), Inc. is an international e-Health medical information technology company providing information management software products and services to the healthcare industry. Its Wyndgate Technologies(R) division is a leading supplier of information management systems to U.S. and international blood centers and hospital transfusion centers. Each year, Wyndgate's products and services manage more than eight million blood components, representing over 27% of the U.S. blood supply. Wyndgate's products are also being used in Canada and sub-Saharan Africa, and are being implemented in the Caribbean. Together, the Donor Doc(TM) interactive donor health history questionnaire, SafeTrace(R) donor management system, and the SafeTrace Tx(R) advanced transfusion management system, recently patented, provide Vein-to-Vein(R) tracking from donor collection to patient transfusion.
This news release may include statements that constitute forward-looking statements, usually containing the words "believe," "estimate," "project," "expects" or similar expressions. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this news release.
|SOURCE Global Med Technologies, Inc.|
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