Daxor Corporation Submits 510(k) to FDA for Next-Generation Blood Volume Analyzer

Core Insights - Daxor Corporation has submitted its next-generation blood volume analyzer, Daxor BVA, to the FDA, aiming to enhance healthcare through improved fluid management [1][3] - The Daxor BVA device offers direct quantification of intravascular blood, red blood cell, and plasma volume, representing a significant advancement over the previous Daxor BVA-100 system [2][3] - The new analyzer is designed to be three times faster in processing, simpler to operate, completely portable, and allows for point-of-care analysis [6] Company Overview - Daxor Corporation is a leader in blood volume measurement technology, having developed the BVA-100, the only FDA-cleared diagnostic blood test for quantifying blood volume status and composition [4] - Over 65,000 tests have been conducted at major hospital centers in the U.S., contributing to improved performance metrics in various medical conditions, particularly in reducing mortality and readmissions in heart failure and critical care [4] - The company is engaged in ongoing trials for heart failure treatment with support from the NIH and is also developing analyzers for combat casualty care under a contract with the U.S. Department of Defense [4]