The Oak Ridge, Tennessee-based company’s next-generation analyzer delivers results three times faster than its predecessor while maintaining laboratory-grade diagnostic precision.
Daxor Corp announced that it received US Food and Drug Administration 510(k) clearance for its next-generation rapid, compact, handheld, 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 clinical conditions affecting millions of patients annually. The system was developed under contract with the US Department of Defense, specifically the US Army and the Defense Health Agency.
“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,” says Michael Feldschuh, Daxor’s president and CEO, in a release. “This critical knowledge gap has impacted treatment decisions across numerous medical specialties.”
The analyzer delivers results three times faster than its predecessor, the Daxor BVA-100, while weighing seven pounds for easy transport between laboratory settings. The device uses gold standard indicator tracer dilution technique to provide objective blood volume measurements.
Improvements with BVA-Guided Care
Clinical studies demonstrate patient outcomes improvements with BVA-guided care. Peer-reviewed research showed blood volume analysis guided care reduced heart failure one-year mortality by 86% and resulted in shorter hospital stays, 56% fewer readmissions and lower healthcare costs. A randomized control trial in intensive care units showed 66% lower mortality in predominantly septic/ARDS patients.
The device addresses volume derangement conditions including heart failure, which affects more than 7 million patients with 1 million hospitalizations annually, and critical care and sepsis, accounting for 7.4 million admissions. Other applications include dialysis, surgical blood loss, traumatic injury and syncope 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,” says John L. Jefferies, Daxor’s chief medical officer, in a release.
The system enables physicians in cardiology, nephrology, critical care, hematology, emergency medicine and primary care to make treatment decisions with precise volume status measurements. This helps clinicians avoid risks associated with both hypovolemia and hypervolemia.
Research supporting BVA-guided care comes from Duke University Medical Center, Cleveland Clinic, Mayo Clinic and the U.S. Department of Veterans Affairs. Daxor has shipped more than 75,000 tests and conducted more than 50 years of research in blood volume measurement technology.
The Oak Ridge-based company operates a 20,000-square-foot manufacturing facility and holds ISO certification for its blood volume analysis diagnostic systems.
