Daxor Corporation, a global leader in blood volume measurement technology, has received FDA 510(k) clearance for its next-generation rapid, compact, hand-held, lab-based Blood Volume Analyzer (BVA). The patent-pending device quantifies a patient’s blood volume against individual norms, enabling precise fluid management across a broad range of 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,” said Michael Feldschuh, Daxor’s president and CEO. “This critical knowledge gap has impacted treatment decisions across numerous specialties. Our next-generation BVA changes the game by delivering faster, more precise blood volume data anywhere there is access to a lab—from the hospital to the outpatient clinic.”

Volume derangement is a silent crisis driving a multi-billion-dollar annual healthcare burden. Conditions such as heart failure – over seven million patients and one million hospitalisations annually – critical care and sepsis (7.4 million admissions), dialysis, surgical blood loss, traumatic injury, and syncope all depend on accurate fluid management.

“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,” said John Jefferies, Daxor’s chief medical officer. “BVA provides precise, objective data, empowering value-based care through better outcomes and fewer hospitalisations.”

Peer-reviewed studies show that BVA-guided care can reduce one-year mortality in heart failure patients by 86%, cut hospital stays, lower readmissions by 56%, and significantly reduce healthcare costs. A randomised control trial in the ICU also demonstrated a 66% reduction in mortality among predominantly septic and ARDS patients.

Building on the success of the BVA-100, the new analyser offers:

• Three times faster results than before

• Lightweight portability at just 7 lbs

• Laboratory-grade diagnostic accuracy

The system was developed under contract with the US Department of Defense, specifically the US Army and the Defense Health Agency, and is intended for use in cardiology, nephrology, critical care, haematology, emergency medicine and primary care.

Research from institutions including Duke University Medical Center, the Cleveland Clinic, the Mayo Clinic and the US Department of Veterans Affairs has validated the benefits of BVA-guided care. With more than 75,000 tests shipped and over 50 years of research, Daxor continues to redefine precision diagnostics.