Daxor Corporation has received US Food and Drug Administration (FDA) 510(k) clearance (K251087) for its next-generation rapid, portable Blood Volume Analyzer (BVA).
The hand-held, lab-based device delivers precise blood volume measurements in a fraction of the time of traditional methods, promising to transform patient fluid management across multiple medical specialties. The new BVA system, developed with support from the National Institutes of Health (NIH) and the US Department of Defense (DoD), measures total blood volume and red blood cell volume directly in minutes.
The Tennessee (US) based company noted that this advance addresses what clinicians describe as a long-standing gap in care: the inability to accurately assess blood volume at the point of care, which has contributed to poor outcomes and high costs in conditions such as heart failure, sepsis, and dialysis.
“For decades, clinicians without access to BVA have been forced to estimate a patient’s blood volume using indirect, often imprecise methods,” said Michael Feldschuh, Daxor’s President and CEO. “Our next-generation device changes the game by providing faster, precise blood volume data wherever there is lab access—from the hospital to outpatient clinics.”
News of the FDA clearance boosted Daxor’s stock by 12.1% in market trading. Shares closed at $10.50 on August 7, up 5% from the previous day’s close.
Proven Clinical Impact
Peer-reviewed studies have shown that BVA-guided care can reduce one-year mortality in heart failure patients by 86% (p<0.001), cut readmissions by 56%, and shorten hospital stays, significantly lowering healthcare costs. In ICU settings, BVA use lowered mortality by 66% among septic and ARDS patients (p<0.03).
The device uses the gold-standard indicator tracer dilution technique, overcoming the limitations of conventional markers such as central venous pressure (CVP), inferior vena cava (IVC) ultrasound, and B-type natriuretic peptide (BNP) levels. By delivering objective, patient-specific data, BVA enables more precise treatment decisions, particularly in complex or critical cases.
Daxor boasted that the new BVA-100 is three times faster and highly portable (weighing seven pounds), compared to its predecessor, while maintaining the precision of established laboratory diagnostics. These improvements open the door for use in a wider range of clinical environments, including resource-limited settings.
Broad Applications Across Specialties
Accurate volume measurement is essential to avoid the dangers of both hypovolemia, linked to acute kidney injury, hypotension, and organ damage, and hypervolemia, which can exacerbate heart failure and other chronic conditions. The newly cleared device is expected to benefit cardiology, nephrology, critical care, hematology, emergency medicine, and primary care.
“This diagnostic innovation is a game-changer for fluid management,” said Dr. John L. Jefferies, Daxor’s Chief Medical Officer. “BVA provides precise, objective data that empowers value-based care through better outcomes and fewer hospitalizations.”
BVA-guided care is supported by decades of research involving leading institutions such as Duke University Medical Center, the Cleveland Clinic, Mayo Clinic, and the US Department of Veterans Affairs. Over 75,000 BVA tests have been shipped, underpinned by more than 50 years of research into precision fluid management, as per Daxor.
The company added that the system’s development included collaboration with the US Army and Defense Health Agency, underscoring its potential utility not only in hospitals but also in military and field medicine.
