Daxor Corporation Streamlines Regulatory Strategy for Groundbreaking Diagnostic Device

Barchart · 09/27 16:00

Company to Focus on 510(k) Approval Path, Accelerating Time-to-Market

Oak Ridge, TN, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Daxor Corporation (NASDAQ: DXR), the global leader in blood volume measurement technology, today announces a strategic update to its regulatory approach for its novel diagnostic blood volume analyzer platform. Following productive discussions with the U.S. Food and Drug Administration (FDA), the company has decided to withdraw its current dual 510(k)/CLIA-waiver application and resubmit a focused 510(k) application.

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