Daxor Corporation announces FDA clearance for a new blood volume analyzer, enhancing clinical precision and efficiency in patient care.
Quiver AI Summary
Daxor Corporation has received FDA 510(k) clearance for its next-generation Blood Volume Analyzer (BVA), a compact, hand-held device that accurately measures a patient's blood volume against personalized norms. This innovation aims to enhance fluid management across various medical conditions, addressing a critical gap where clinicians previously relied on imprecise methods. The BVA’s ability to deliver rapid, accurate data could significantly improve patient outcomes, particularly for those with heart failure and critical care needs, by reducing hospital stays and readmission rates. Developed with the U.S. Department of Defense, this device exemplifies Daxor’s commitment to precision diagnostics, with over 75,000 tests conducted and collaborations with leading healthcare institutions supporting its efficacy. The BVA is poised to transform clinical practices by enabling tailored treatment strategies and improving overall healthcare value.
Potential Positives
- Daxor Corporation received FDA 510(k) clearance for their next-generation Blood Volume Analyzer (BVA), enhancing its market position and product credibility.
- The BVA device enables precise fluid management in various clinical conditions affecting millions of patients, thus addressing a significant healthcare need.
- Clinical studies indicate BVA-guided care reduces one-year mortality in heart failure patients by 86% and overall healthcare costs, supporting the device's effectiveness.
- The rapid, lightweight design of the BVA facilitates broader use in diverse clinical settings, potentially increasing adoption rates among healthcare providers.
Potential Negatives
- Reliance on forward-looking statements introduces uncertainty about the company’s future product acceptance and market performance, which could deter investors.
- The mention of potential risks associated with post-market clinical data collection may raise concerns about the reliability and safety of the new product.
- Competition and the potential for new product offerings from other companies could threaten Daxor's market position and expectations outlined in the press release.
FAQ
What is the new Daxor BVA device?
The Daxor BVA is a next-generation, hand-held device that measures blood volume accurately using a lab-based diagnostic method.
How does the Daxor BVA improve patient care?
The device provides precise blood volume measurements, aiding fluid management and improving treatment outcomes for various medical conditions.
What are the benefits of using Daxor's Blood Volume Analyzer?
Benefits include faster results, improved diagnostic accuracy, reduced readmissions, and lower healthcare costs for patients with volume-related conditions.
Which medical specialties can benefit from Daxor BVA?
Cardiology, nephrology, critical care, emergency medicine, and primary care can all utilize the Daxor BVA for tailored treatments.
What research supports the effectiveness of the Daxor BVA?
Studies show that BVA-guided care significantly reduces mortality, readmissions, and hospital stays across various patient populations.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$DXR Insider Trading Activity
$DXR insiders have traded $DXR stock on the open market 3 times in the past 6 months. Of those trades, 3 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $DXR stock by insiders over the last 6 months:
- MICHAEL RICHARD FELDSCHUH (Chief Executive Officer) has made 2 purchases buying 5,423 shares for an estimated $42,081 and 0 sales.
- ROBERT J MICHEL (Chief Financial Officer) purchased 1,000 shares for an estimated $8,000
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$DXR Hedge Fund Activity
We have seen 3 institutional investors add shares of $DXR stock to their portfolio, and 4 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- UBS GROUP AG removed 2,273 shares (-87.5%) from their portfolio in Q1 2025, for an estimated $18,456
- KEYES, STANGE & WOOTEN WEALTH MANAGEMENT, LLC added 1,302 shares (+8.9%) to their portfolio in Q1 2025, for an estimated $10,572
- PRINCETON GLOBAL ASSET MANAGEMENT LLC removed 500 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $4,059
- RENAISSANCE TECHNOLOGIES LLC added 300 shares (+1.1%) to their portfolio in Q1 2025, for an estimated $2,435
- VANGUARD GROUP INC added 200 shares (+0.4%) to their portfolio in Q1 2025, for an estimated $1,623
- MORGAN STANLEY removed 1 shares (-1.1%) from their portfolio in Q1 2025, for an estimated $8
- JPMORGAN CHASE & CO removed 1 shares (-20.0%) from their portfolio in Q1 2025, for an estimated $8
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$DXR Analyst Ratings
Wall Street analysts have issued reports on $DXR in the last several months. We have seen 1 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Ascendiant Capital issued a "Buy" rating on 03/17/2025
To track analyst ratings and price targets for $DXR, check out Quiver Quantitative's $DXR forecast page.
Full Release
Management Expects High Demand Driven by Speed, Simplicity, and Clinical Precision
Oak Ridge, TN, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Daxor Corporation (NASDAQ: DXR), the global leader in blood volume measurement technology, today announces FDA 510(k) clearance (K251087) for its patent-pending next-generation rapid, compact, hand-held, lab-based Blood Volume Analyzer (BVA). The new Daxor BVA ™ device quantifies a patient’s blood volume against patient-specific norms, enabling precise fluid management across a broad spectrum of clinical conditions affecting millions of patients each year.
“For decades, clinicians without access to BVA have been forced to estimate a patient’s blood volume status using indirect, often invasive, or imprecise methods,” said Michael Feldschuh, Daxor’s President and CEO. “This critical knowledge gap has impacted treatment decisions across numerous medical specialties. Daxor’s next generation BVA device changes the game by delivering even faster, precise blood volume data anywhere there is access to a laboratory—from the hospital to the outpatient clinic.”
Volume derangement is a silent crisis driving a multi-billion annual healthcare burden. Conditions such as heart failure (over seven million patients and one million hospitalizations annually), critical care and sepsis (7.4 million admissions), dialysis, surgical blood loss, traumatic injury, and syncope all depend on accurate fluid management.
“Our diagnostic innovation is a game-changer for fluid management,” said John L. Jefferies, MD, MPH, MBA, Daxor's Chief Medical Officer. “By using the gold standard indicator tracer dilution technique, we can overcome the inaccuracies of traditional clinical assessments, especially in patients with multiple and complex conditions. BVA provides precise, objective data, empowering value-based care through better outcomes and fewer hospitalizations.”
In peer-reviewed studies, blood volume analysis guided care was associated with reduced heart failure one-year mortality by 86% , (p<0.001). It also demonstrated shorter hospital stays , 56% fewer readmissions, and significantly lower healthcare costs . Data from a randomized control trial in the ICU also showed significant benefit with BVA-guided care, lowering mortality by 66% in a cohort of predominantly septic/ARDS patients (p<0.03).
Building upon the success of its predecessor, the Daxor BVA-100 ™ , this next generation analyzer redefines efficiency enabling far broader use in clinical settings where resources are limited:
- 3x Faster: Provides critical results in one-third the time
- Lightweight: Moves easily between laboratory settings, weighs just 7 lbs.
- Highly Accurate: Delivers laboratory-grade diagnostic precision
The newly FDA-cleared rapid, hand-held, modular, lab-based diagnostic enables physicians in cardiology, nephrology, critical care, hematology, emergency medicine, and primary care to tailor treatment with confidence. By accurately measuring volume status, clinicians can avoid the risks of hypovolemia—including tissue hypoperfusion, acute kidney injury, hypotension, syncope, and organ damage—as well as hypervolemia, which can lead to heart failure decompensation, accelerated disease progression, and further organ damage. This new system was developed under contract with the U.S. Department of Defense, specifically the U.S. Army and the Defense Health Agency.
Research from leading institutions—including Duke University Medical Center, the Cleveland Clinic, the Mayo Clinic, and the U.S. Department of Veterans Affairs—has proven the utility of BVA-guided care. This approach has been shown to reduce mortality, readmissions, and hospital length of stay. With over 75,000 tests shipped and more than 50 years of groundbreaking research, including collaborations with some of leading experts in cardiology care, Daxor is redefining precision diagnostics.
About Daxor Corporation
Daxor Corporation (NASDAQ: DXR) is tackling healthcare's "multi-billion-dollar silent crisis", the inability to precisely measure blood volume. This often results in suboptimal care, prolonged hospital stays, and increased readmissions for many high-cost medical conditions like heart failure and those requiring ICU care. With 50 years of experience and innovation, Daxor's patented, FDA-cleared Blood Volume Analysis (BVA) diagnostic offers unmatched, real-time, precise data via its rapid, hand-held lab-based system. This empowers clinicians to make individualized treatment decisions that significantly improve patient outcomes and deliver substantial efficiencies in value-based healthcare. Daxor is ISO certified and operates a U.S.-based, 20,000-square-foot state-of-the-art manufacturing facility, positioning the company for accelerated market expansion.
For more information, visit www.daxor.com .
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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
COO - Head of Capital Markets
COREIR
(561)-479-8566-Cell
[email protected]
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