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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News
- Daxor Expands Its BVA-100™ Blood Volume Diagnostic to Two New Hospital Systems Adding to Sales Momentum [Yahoo! Finance]Yahoo! Finance
- Daxor Expands Its BVA-100™ Blood Volume Diagnostic to Two New Hospital Systems Adding to Sales MomentumGlobeNewswire
- DAXOR'S INNOVATIVE BVA-100™ BLOOD VOLUME DIAGNOSTIC FEATURED AT MEDAXIOM CV TRANSFORUM FALL '24GlobeNewswire
- Daxor Corporation to Participate in a Fireside Chat at the 2024 Maxim Healthcare Virtual SummitGlobeNewswire
- Daxor Corporation Streamlines Regulatory Strategy for Groundbreaking Diagnostic Device [Yahoo! Finance]Yahoo! Finance
DXR
Sec Filings
- 12/10/24 - Form 4
- 12/10/24 - Form 4
- 12/10/24 - Form 4
- DXR's page on the SEC website