Daxor Corporation, a global provider in blood volume measurement technology, has submitted its next-generation blood volume analyzer—Daxor BVA—to the U.S. Food and Drug Administration (FDA) via the 510(k)/CLIA-waiver dual submission pathway. Potential clearance is expected during the first half of 2024.
The new Daxor BVA device directly quantifies the intravascular blood, red blood cell, and plasma volume, providing clinicians with actionable information to achieve optimal fluid management for their patients. Compared to the current Daxor BVA-100 system, the new Daxor BVA is designed to be three times faster, simpler to operate, completely portable, and capable of performing bedside analysis, making it easier for healthcare providers to integrate this innovative diagnostic into their clinical workflow.
Further reading: Daxor Awarded Contract to Improve POC Blood Volume Analyzer
“Today marks a long-anticipated and momentous milestone in our continued commitment to our customers, patients, and to achieving our vision of optimal blood volume for all,” says Michael Feldschuh, Daxor’s CEO and president. “Funded under contract by the U.S. Department of Defense, our next-generation analyzer will deliver a level of speed, access, and accuracy to blood volume management that can significantly improve care and outcomes in medicine.”
Daxor is a global provider in blood volume measurement technology focused on blood volume testing innovation. The company developed and marketed the BVA-100 (Blood Volume Analyzer)—a diagnostic blood test cleared by the FDA—to provide safe, accurate, objective quantification of blood volume status and composition compared to patient-specific norms.
