DAXOR CORPORATION RECEIVES ISO 13485 QUALITY MANAGEMENT SYSTEM CERTIFICATION FOR THE BLOOD VOLUME ANALYZER (BVA-100®)
February 19 2021 - 8:30AM
Daxor Corporation (NYSE MKT: DXR), the global leader in blood
volume measurement technology, announces today that it has been
officially recognized as meeting all the requirements of ISO 13485;
Medical Devices, Quality Management System Certification ensuring
the consistent design, development, production, installation, and
delivery for the Blood Volume Analyzer (BVA-100®) system is safe
for its intended purpose.
“This opens the way for Daxor to international
distribution by meeting all the rigorous requirements of ISO 13485
certification -- this is a proud achievement for Daxor,” said
Michael Feldschuh, President and CEO of Daxor Corporation. “Being
recognized as meeting the “gold standard” for quality will enable
us to expand the availability of our products outside the U.S. and
amplify the efforts currently underway domestically through our
sales force expansion and third-party distribution partners.”
“Achieving ISO 13485 with full design
certification is a key milestone for Daxor,” said James Adkins,
Head of Quality Engineering. “Certification to this
internationally-recognized standard proves to our customers that we
take quality very seriously, and that we have a validated system in
place to ensure it.”
About Daxor Corporation
Daxor Corporation (NYSE: DXR) is the global
leader in blood volume measurement technology focused on blood
volume testing innovation (organized as an investment company with
fully-owned innovative medical instrumentation and biotechnology
operations). We developed and market the BVA-100® (Blood Volume
Analyzer), the first diagnostic blood test cleared by the FDA to
provide safe, accurate, objective quantification of blood volume
status and composition compared to patient-specific norms. The BVA
technology enhances hospital performance metrics in a broad range
of surgical and medical conditions, including heart failure and
critical care, by informing treatment strategies, resulting in
significantly improved multiple measures of patient outcomes.
Daxor's mission is to advance healthcare by enabling optimal fluid
management with blood volume analysis. Daxor’s vision is optimal
blood volume for all. For more information, please visit our
website at Daxor.com.
Forward-Looking Statements
Certain statements in this release may include
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including without
limitation, statements regarding the impact of hiring sales staff
and expansion of our distribution channels. Forward-looking
statements are predictions, projections and other statements about
future events that are based on current expectations and
assumptions and, as a result, are subject to risks and
uncertainties. Many factors could cause actual future events to
differ materially from the forward-looking statements in this
release, including, without limitation, those risk associated with
our post-market clinical data collection activities, benefits of
our products to patients, our expectations with respect to product
development and commercialization efforts, our ability to increase
market and physician acceptance of our products, potentially
competitive product offerings, intellectual property protection,
FDA regulatory actions, our ability to integrate acquired
businesses, our expectations regarding anticipated synergies with
and benefits from acquired businesses, and additional other risks
and uncertainties described in our filings with the SEC.
Forward-looking statements speak only as of the date when made.
Daxor does not assume any obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor Relations Contact:Bret ShapiroSr.
Managing Partner, CORE IR516-222-2560brets@coreir.com
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