Daxor Corporation Submits Dual 510(k)/CLIA-waiver Application to the FDA for Its Advanced Next-Generation Blood Volume Analyzer
2024年1月2日 - 10:30PM
Daxor Corporation (Nasdaq: DXR), the global leader in blood volume
measurement technology, today announces it has submitted its
next-generation blood volume analyzer - Daxor BVA - to the U.S.
Food and Drug Administration (FDA) via the 510(k)/CLIA-waiver dual
submission pathway. Potential clearance is expected during the
first half of 2024. The Company’s mission is to advance healthcare
by enabling optimal fluid management.
The new Daxor BVA device directly quantifies the
intravascular blood, red blood cell and plasma volume, providing
clinicians with actionable information to achieve optimal fluid
management for their patients. Compared to the current Daxor
BVA-100 system, the new Daxor BVA is designed to be three times
faster, simpler to operate, completely portable, and capable of
performing bedside analysis, making it easier for healthcare
providers to integrate this innovative diagnostic into their
clinical workflow.
“Today marks a long-anticipated and momentous
milestone in our continued commitment to our customers, patients,
and to achieving our vision of optimal blood volume for all,” said
Michael Feldschuh, Daxor’s CEO and President. “Funded under
contract by the U.S. Department of Defense, our next-generation
analyzer will deliver a level of speed, access, and accuracy to
blood volume management that can significantly improve care and
outcomes in medicine.”
About Daxor Corporation
Daxor Corporation (Nasdaq: DXR), is the global
leader in blood volume measurement technology focused on blood
volume testing innovation. We developed and market the BVA-100®
(Blood Volume Analyzer), the only diagnostic blood test cleared by
the FDA to provide safe, accurate, objective quantification of
blood volume status and composition compared to patient-specific
norms. Over 65,000+ tests have been performed at leading hospital
centers across the U.S., enhancing hospital performance metrics in
a broad range of surgical and medical conditions, including
significantly reducing mortality and readmissions in heart failure
and critical care. Daxor has several ongoing trials in the areas of
heart failure treatment with support from the NIH and is under
contract developing analyzers to improve combat casualty care with
the U.S. Department of Defense. 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. Sign up to
receive news on Daxor’s innovative technology HERE.
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 IR1-516-222-2560brets@coreir.com
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