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Global Med Technologies(R), Inc. Receives FDA 510(K) Clearance For ElDorado Donor(TM)
Global Med Technologies(R),
Inc. (OTC Bulletin Board: GLOB), an international e-Health, medical
information technology company, announced that the U.S. Food and Drug
Administration has granted 510(k) clearance for ElDorado Donor(TM) a new
blood management product produced by its Wyndgate Technologies(R) division
("Wyndgate"), paving the way for the Company to proceed marketing the
product in the United States.
The ElDorado Donor release is the Company's next generation software
and is intended as a comprehensive blood management software application
created to provide for the information system needs of 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. The release marks a new growth
opportunity for the Company 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 supporting process control from
collection to distribution. The software was created for ease-of-use which
includes drop down lists and easy access "find" forms. Wyndgate's
At-a-Glance(TM) bars provide visual indications of the presence of relevant
information offering quick and easy access to that information. ElDorado
Donor is designed to support the industry standard for labeling (ISBT128),
as well as the ABC Codabar blood product labeling standard.
ElDorado Donor includes safety checks for blood components, blood
products, and other related supply items. Safety checks are performed
throughout the system as part of the normal processing of donors, blood
components, and other blood products. ElDorado Donor can provide extensive
manufacturing controls that can be tailored for a specific site depending
on its processes.
The blood management software was designed with guidance from
Wyndgate's Technology Work Group ("TWG"), comprised of leading industry
representatives from around the world. Throughout the ElDorado Donor
development process, the TWG contributions assisted the Company in
delivering a feature-rich and user-friendly solution.
Thomas F. Marcinek, President and Chief Operating Officer, commented,
"We are delighted that ElDorado Donor has received FDA clearance for
marketing. The Company has made a serious commitment to our customers by
continuing to invest in innovations which help them meet their business and
regulatory needs." Mr. Marcinek further commented, "Global Med is dedicated
to providing solutions and services that help support and protect the
public's health. We value the trust that our customers place in us, and
their continued efforts to improve the safety of the blood supply. We
believe that the introduction of ElDorado Donor brings us closer to our
goal of becoming the world leader in blood management software and
services."
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. Global Med's PeopleMed(R), Inc.
subsidiary provides custom software validation, consulting and compliance
solutions to hospitals and blood centers. PeopleMed's in-depth knowledge of
Wyndgate's products and the blood banking industry results in
cost-effective validation services, which leads to more efficient software
implementations and upgrades for our customers.
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.
Global Med Technologies, Inc.
http://www.globalmedtech.com
Global Med Tehnologii (R), Inc FDA a primit 510 (K) Pentru clearance-ul a donatorului de Eldorado (TM) - Global Med Technologies(R), Inc. Receives FDA 510(K) Clearance For ElDorado Donor(TM) - articole medicale engleza - startsanatate