Global Med Technologies(R), Inc. Recieves FDA 510(K) Clearance for ElDorado Donor(TM)
February 15 2008 - 9:00AM
PR Newswire (US)
DENVER, Feb. 15 /PRNewswire-FirstCall/ -- Global Med
Technologies(R), Inc. (OTC:GLOB) (BULLETIN BOARD: GLOB) , an
international e-Health, medical information technology company,
announced today 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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20040226/GLOBALMEDLOGO) 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. For more
information about Global Med's products and services, please call
800-WYNDGATE or visit http://www.globalmedtech.com/,
http://www.peoplemed.com/ and http://www.wyndgate.com/. 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.
http://www.newscom.com/cgi-bin/prnh/20040226/GLOBALMEDLOGO
http://photoarchive.ap.org/ DATASOURCE: Global Med Technologies,
Inc. CONTACT: Michael I. Ruxin, M.D. of Global Med Technologies,
Inc., +1-303-238-2000, ; or investors, Paul Holm, President of
portfoliopr.inc, +1-212-999-5585, , for Global Med Technologies,
Inc. Web site: http://www.globalmedtech.com/
http://www.peoplemed.com/ http://www.wyndgate.com/
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