regulatory
confidence high
sentiment neutral
materiality 0.65
Daxor submits next-gen BVA to FDA for 510(k)/CLIA-waiver; clearance expected H1 2024
DAXOR CORP
- Submission via dual 510(k)/CLIA-waiver pathway to FDA for next-generation blood volume analyzer.
- New device designed to be three times faster, simpler, portable, and capable of bedside analysis.
- Development funded under contract by U.S. Department of Defense.
- Potential FDA clearance is expected during the first half of 2024.
- Current BVA-100 is only FDA-cleared diagnostic for direct blood volume measurement.