Daxor Corporation Receives FDA Clearance for New Rapid, Lightweight, Blood Volume Analysis System
Daxor Corporation (NASDAQ: DXR) has received FDA 510(k) clearance for its next-generation Blood Volume Analyzer (BVA), a revolutionary diagnostic device for precise fluid management. The new hand-held, lab-based system offers significant improvements over its predecessor, being 3x faster and weighing only 7 pounds.
The device addresses critical healthcare challenges across multiple conditions, including heart failure, critical care, and sepsis. Clinical studies have shown remarkable results, with BVA-guided care reducing heart failure mortality by 86% and demonstrating 66% lower mortality in ICU patients. The system also helped achieve 56% fewer hospital readmissions and shorter hospital stays.
Developed in collaboration with the U.S. Department of Defense, the technology builds on Daxor's extensive experience with over 75,000 tests shipped and 50 years of research.
Daxor Corporation (NASDAQ: DXR) ha ottenuto l'approvazione FDA 510(k) per il suo Blood Volume Analyzer (BVA) di nuova generazione, un dispositivo diagnostico rivoluzionario per una gestione precisa dei fluidi. Il nuovo sistema portatile, da laboratorio offre miglioramenti significativi rispetto al modello precedente, essendo 3 volte più veloce e pesando solo 7 libbre.
Il dispositivo affronta sfide critiche nel settore sanitario in diverse condizioni, tra cui insufficienza cardiaca, terapia intensiva e sepsi. Studi clinici hanno evidenziato risultati straordinari, con una riduzione della mortalità per insufficienza cardiaca dell'86% guidata dal BVA e una mortalità inferiore del 66% nei pazienti in terapia intensiva. Il sistema ha inoltre contribuito a ridurre del 56% le riammissioni ospedaliere e a ridurre la durata delle degenze.
Sviluppata in collaborazione con il Dipartimento della Difesa degli Stati Uniti, la tecnologia si basa sull'ampia esperienza di Daxor con oltre 75.000 test distribuiti e 50 anni di ricerca.
Daxor Corporation (NASDAQ: DXR) ha recibido la autorización FDA 510(k) para su analizador de volumen sanguíneo (BVA) de próxima generación, un dispositivo diagnóstico revolucionario para una gestión precisa de líquidos. El nuevo sistema portátil, basado en laboratorio ofrece mejoras significativas respecto a su predecesor, siendo 3 veces más rápido y pesando solo 7 libras.
El dispositivo aborda desafíos críticos en la atención médica para múltiples condiciones, incluyendo insuficiencia cardíaca, cuidados intensivos y sepsis. Estudios clínicos han demostrado resultados notables, con una reducción del 86% en la mortalidad por insuficiencia cardíaca guiada por BVA y una mortalidad un 66% menor en pacientes de UCI. El sistema también ayudó a lograr 56% menos readmisiones hospitalarias y estancias hospitalarias más cortas.
Desarrollada en colaboración con el Departamento de Defensa de EE.UU., la tecnología se basa en la amplia experiencia de Daxor con más de 75,000 pruebas enviadas y 50 años de investigación.
Daxor Corporation (NASDAQ: DXR)는 차세대 혈액량 분석기(BVA)에 대해 FDA 510(k) 승인을 받았습니다. 이 혁신적인 진단 장치는 정확한 체액 관리를 제공합니다. 새로운 휴대용 실험실 기반 시스템은 이전 모델보다 3배 빠르며, 무게는 단지 7파운드에 불과합니다.
이 장치는 심부전, 중환자 치료, 패혈증 등 다양한 질환에서 중요한 의료 문제를 해결합니다. 임상 연구 결과, BVA 기반 치료가 심부전 사망률을 86% 감소시키고, 중환자실 환자의 사망률을 66% 낮췄습니다. 또한 이 시스템은 병원 재입원율을 56% 줄이고, 입원 기간을 단축하는 데 도움을 주었습니다.
미국 국방부와 협력하여 개발된 이 기술은 Daxor가 50년간 연구하며 75,000건 이상의 테스트를 수행한 풍부한 경험을 바탕으로 합니다.
Daxor Corporation (NASDAQ : DXR) a obtenu l'autorisation FDA 510(k) pour son analyseur de volume sanguin (BVA) de nouvelle génération, un dispositif de diagnostic révolutionnaire pour une gestion précise des fluides. Le nouveau système portable, basé en laboratoire offre des améliorations significatives par rapport à son prédécesseur, étant 3 fois plus rapide et ne pesant que 7 livres.
Le dispositif répond à des défis critiques en santé dans plusieurs pathologies, notamment l'insuffisance cardiaque, les soins intensifs et la septicémie. Des études cliniques ont montré des résultats remarquables, avec une réduction de 86 % de la mortalité liée à l’insuffisance cardiaque grâce aux soins guidés par le BVA et une mortalité réduite de 66 % chez les patients en soins intensifs. Le système a également permis d’obtenir 56 % de réadmissions hospitalières en moins et des séjours hospitaliers plus courts.
Développée en collaboration avec le Département de la Défense des États-Unis, la technologie s’appuie sur l’expérience approfondie de Daxor, avec plus de 75 000 tests réalisés et 50 ans de recherche.
Daxor Corporation (NASDAQ: DXR) hat die FDA 510(k)-Zulassung für seinen Blutvolumen-Analysator (BVA) der nächsten Generation erhalten, ein revolutionäres Diagnosegerät für präzises Flüssigkeitsmanagement. Das neue tragbare, laborbasierte System bietet erhebliche Verbesserungen gegenüber dem Vorgänger, ist dreimal schneller und wiegt nur 7 Pfund.
Das Gerät adressiert kritische Herausforderungen im Gesundheitswesen bei verschiedenen Erkrankungen, darunter Herzinsuffizienz, Intensivpflege und Sepsis. Klinische Studien zeigten bemerkenswerte Ergebnisse, mit einer um 86 % reduzierten Herzinsuffizienz-Sterblichkeit durch BVA-gestützte Behandlung und 66 % geringerer Sterblichkeit bei Intensivpatienten. Das System trug zudem zu 56 % weniger Krankenhauswiederaufnahmen und kürzeren Krankenhausaufenthalten bei.
Die in Zusammenarbeit mit dem US-Verteidigungsministerium entwickelte Technologie basiert auf Daxors umfangreicher Erfahrung mit über 75.000 durchgeführten Tests und 50 Jahren Forschung.
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Insights
Daxor's FDA clearance for faster, portable blood volume analyzer addresses critical clinical needs with proven mortality benefits.
Daxor's FDA 510(k) clearance for its next-generation Blood Volume Analyzer represents a significant milestone for the company's diagnostic portfolio. The new device maintains the clinical gold standard tracer dilution technique while delivering results three times faster than its predecessor in a dramatically lighter 7-pound form factor.
The clinical impact potential is substantial. Blood volume measurement addresses a critical diagnostic gap in several high-burden conditions. In heart failure management, which affects over 7 million patients with 1 million hospitalizations annually, BVA-guided care has demonstrated an impressive 86% reduction in one-year mortality (p<0.001) in peer-reviewed studies. Similarly, in ICU settings, predominantly with sepsis/ARDS patients, BVA-guided care showed a 66% reduction in mortality (p<0.03).
Beyond mortality benefits, the technology has demonstrated meaningful healthcare economic advantages: shorter hospital stays, 56% fewer readmissions, and significantly lower costs. These metrics align perfectly with value-based care initiatives and could drive adoption.
The technology's development under Department of Defense contracts adds credibility, while validation from prestigious institutions like Duke, Cleveland Clinic, and Mayo Clinic strengthens its clinical positioning. The device's portability and speed improvements specifically address practical implementation barriers that likely limited wider adoption of the previous generation BVA-100™.
With applications across cardiology, nephrology, critical care, hematology, emergency medicine, and primary care, this approval substantially expands Daxor's addressable market within the multi-billion dollar fluid management diagnostic space.
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
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
brets@coreir.com|www.coreir.com
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