Daxor Corporation Submits 510(k) to FDA for Next-Generation Blood Volume Analyzer
Rhea-AI Summary
Daxor (Nasdaq: DXR) has submitted its next-generation blood volume analyzer, Daxor BVA, to the FDA for 510(k) approval. The new device represents a significant advancement in blood volume measurement technology, offering direct quantification of intravascular blood, red blood cell, and plasma volume.
The next-generation analyzer, developed under a U.S. Department of Defense contract, boasts several improvements over its predecessor, the BVA-100™ system, including:
- Three times faster processing
- Significantly simpler operation
- Complete portability
- Point of care analysis capabilities
These enhancements are designed to facilitate seamless integration of advanced blood volume diagnostics into clinical workflows, potentially improving medical care and patient outcomes.
Positive
- Development of technologically advanced blood volume analyzer with improved features
- Product developed under U.S. Department of Defense contract, indicating government backing
- Three-fold increase in processing speed compared to previous model
- Enhanced portability and point-of-care capabilities expanding potential market reach
Negative
- FDA approval pending, creating uncertainty about market launch timeline
- Potential competition from existing point-of-care diagnostic devices
News Market Reaction
On the day this news was published, DXR gained 1.13%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Advanced BVA System Designed for Faster, Simpler Bedside Testing
Oak Ridge, TN, April 10, 2025 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), a leader in blood volume measurement technology, announces today the submission of its next-generation blood volume analyzer - Daxor BVA - to the Food and Drug Administration (FDA.), advancing its mission to optimize healthcare through precise fluid management.
The new Daxor BVA device represents a significant leap forward in diagnostic technology, offering direct quantification of intravascular blood, red blood cell, and plasma volume. Unlike its predecessor, the Daxor BVA-100™ system, this innovative analyzer is engineered to be:
- Three times faster in processing
- Significantly simpler to operate
- Completely portable
- Allows for point of care analysis
These features will enable healthcare providers to more seamlessly integrate advanced blood volume diagnostics into clinical workflows.
“This submission represents a long-anticipated milestone in our commitment to patients and healthcare providers," said Michael Feldschuh, Daxor's CEO and President. "Developed under a U.S. Department of Defense contract, our next-generation analyzer promises to deliver unprecedented speed, accessibility, and accuracy in blood volume management, with the potential to meaningfully improve medical care and patient outcomes.”
The Daxor BVA system underscores the company's ongoing innovation in diagnostic technologies, bringing sophisticated blood volume analysis closer to the point of care.
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 Shapiro
Sr. Managing Partner, CORE IR
1-516-222-2560
brets@coreir.com
FAQ
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