2024 | HFSA

Daxor Corporation Submits Dual 510(k)/CLIA-waiver Application to the FDA for Its Advanced Next-Generation Blood Volume Analyzer

Industry News In The News

Oak Ridge, TN – January 2, 2024 — Daxor Corporation (NASDAQ: DXR), the global leader in blood volume measurement technology, today announces it 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 Company’s mission is to advance healthcare by enabling optimal fluid management.

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.