Daxor Corporation Submits 510(k) to FDA for Next-Generation Blood Volume Analyzer
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.
Daxor (Nasdaq: DXR) ha presentato il suo analizzatore di volume sanguigno di nuova generazione, Daxor BVA, alla FDA per l'approvazione 510(k). Il nuovo dispositivo rappresenta un avanzamento significativo nella tecnologia di misurazione del volume sanguigno, offrendo una quantificazione diretta del sangue intravascolare, dei globuli rossi e del volume plasmatico.
L'analizzatore di nuova generazione, sviluppato sotto un contratto del Dipartimento della Difesa degli Stati Uniti, vanta diversi miglioramenti rispetto al suo predecessore, il sistema BVA-100™, tra cui:
- Elaborazione tre volte più veloce
- Funzionamento significativamente più semplice
- Completamente portatile
- Capacità di analisi al punto di cura
Questi miglioramenti sono progettati per facilitare l'integrazione fluida delle diagnosi avanzate del volume sanguigno nei flussi di lavoro clinici, potenzialmente migliorando l'assistenza medica e i risultati per i pazienti.
Daxor (Nasdaq: DXR) ha presentado su analizador de volumen sanguíneo de nueva generación, Daxor BVA, a la FDA para la aprobación 510(k). El nuevo dispositivo representa un avance significativo en la tecnología de medición del volumen sanguíneo, ofreciendo una cuantificación directa de la sangre intravascular, los glóbulos rojos y el volumen plasmático.
El analizador de nueva generación, desarrollado bajo un contrato del Departamento de Defensa de EE. UU., cuenta con varias mejoras respecto a su predecesor, el sistema BVA-100™, incluyendo:
- Procesamiento tres veces más rápido
- Operación significativamente más sencilla
- Completamente portátil
- Capacidades de análisis en el punto de atención
Estas mejoras están diseñadas para facilitar la integración fluida de diagnósticos avanzados del volumen sanguíneo en los flujos de trabajo clínicos, lo que podría mejorar la atención médica y los resultados para los pacientes.
Daxor (Nasdaq: DXR)는 차세대 혈액량 분석기인 Daxor BVA를 FDA에 510(k) 승인을 위해 제출했습니다. 이 새로운 장치는 혈액량 측정 기술에서 중요한 발전을 나타내며, 혈관 내 혈액, 적혈구 및 혈장량의 직접적인 정량화를 제공합니다.
미국 국방부 계약에 따라 개발된 차세대 분석기는 이전 모델인 BVA-100™ 시스템에 비해 여러 가지 개선 사항을 자랑합니다.
- 처리 속도 3배 향상
- 상당히 간단한 작동
- 완전한 휴대성
- 진료 현장에서의 분석 기능
이러한 개선 사항은 고급 혈액량 진단을 임상 작업 흐름에 원활하게 통합하도록 설계되어 있으며, 의료 서비스와 환자 결과를 개선할 수 있는 잠재력을 가지고 있습니다.
Daxor (Nasdaq: DXR) a soumis son analyseur de volume sanguin de nouvelle génération, Daxor BVA, à la FDA pour approbation 510(k). Le nouvel appareil représente une avancée significative dans la technologie de mesure du volume sanguin, offrant une quantification directe du sang intravasculaire, des globules rouges et du volume plasmatique.
L'analyseur de nouvelle génération, développé dans le cadre d'un contrat du Département de la Défense des États-Unis, présente plusieurs améliorations par rapport à son prédécesseur, le système BVA-100™, notamment :
- Traitement trois fois plus rapide
- Fonctionnement considérablement simplifié
- Portabilité complète
- Capacités d'analyse au point de soins
Ces améliorations sont conçues pour faciliter l'intégration fluide des diagnostics avancés du volume sanguin dans les flux de travail cliniques, ce qui pourrait améliorer les soins médicaux et les résultats pour les patients.
Daxor (Nasdaq: DXR) hat seinen nächsten Blutvolumenanalysator, Daxor BVA, zur FDA zur Genehmigung nach 510(k) eingereicht. Das neue Gerät stellt einen bedeutenden Fortschritt in der Technologie zur Messung des Blutvolumens dar und bietet eine direkte Quantifizierung des intravasalen Blutes, der roten Blutkörperchen und des Plasma-Volumens.
Der nächste Analysator, der unter einem Vertrag des US-Verteidigungsministeriums entwickelt wurde, bietet mehrere Verbesserungen im Vergleich zu seinem Vorgänger, dem BVA-100™-System, darunter:
- Dreimal schnellere Verarbeitung
- Deutlich einfachere Bedienung
- Vollständige Tragbarkeit
- Analysefähigkeiten am Point of Care
Diese Verbesserungen sind darauf ausgelegt, die nahtlose Integration fortschrittlicher Blutvolumendiagnostik in klinische Arbeitsabläufe zu erleichtern, was potenziell die medizinische Versorgung und die Ergebnisse für die Patienten verbessern könnte.
- 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
- FDA approval pending, creating uncertainty about market launch timeline
- Potential competition from existing point-of-care diagnostic devices
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
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