Important Milestone for International Distribution
NEW YORK, FEBRUARY 19, 2021– 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 (Nasdaq: 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.
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.
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