FDA Clears Daxor Corporation’s Rapid Blood Volume Analysis System

Daxor Corporation has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation lab-based Blood Volume Analyzer (BVA), a device that quantifies a patient’s blood volume against patient-specific norms, enabling precise fluid management across various clinical conditions.

“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,” Daxor President/CEO Michael Feldschuh said. “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 (more than 7 million patients and 1 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,” Daxor Chief Medical Officer John L. Jefferies, M.D., stated. “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, according to Daxor. 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 handheld compact analyzer redefines efficiency enabling far broader use in clinical settings where resources are limited:

• Three times faster: Provides critical results in one-third the time
• Lightweight: Moves easily between laboratory settings, weighs 7 pounds
• Highly accurate: Delivers laboratory-grade diagnostic precision

Daxor’s rapid, 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.

Daxor Corporation 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 diagnostic offers real-time, precise data through 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.