Daxor Corporation Streamlines Regulatory Strategy for Groundbreaking Diagnostic Device
Daxor Corporation - Closed End Fund (DXR)
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Source: GlobeNewswire
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. This decision comes after considerable progress in addressing key regulatory considerations and aims to expedite the approval process, potentially bringing this innovative technology to patients sooner. "We're excited about the positive momentum in our discussions with the FDA," said Daxor CEO and President, Michael Feldschuh. "Our team has made substantial strides in resolving critical issues, and this strategic shift allows us to capitalize on that
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- Daxor Corporation Streamlines Regulatory Strategy for Groundbreaking Diagnostic Device [Yahoo! Finance]Yahoo! Finance
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DXR
Analyst Actions
- 9/9/24 - Ascendiant Capital
DXR
Sec Filings
- 11/21/24 - Form NPORT-P
- 9/10/24 - Form N-PX
- 8/29/24 - Form NPORT-P
- DXR's page on the SEC website