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Co-Diagnostics outlines FDA dual 510(k) and CLIA waiver submission as cash falls to $3.6 M
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Fusion42 · 13 August 2026 · Fusion42 review
Co-Diagnostics is progressing with FDA dual 510(k) and CLIA waiver submissions for its diagnostic products while its cash reserves have fallen to $3.6 million, highlighting critical regulatory milestones amid financial tightening.
This Wire brief sits within Fusion42's coverage of Diagnostics.
◆ ◆ The Wire takeaway
You face a narrowing runway as Co-Diagnostics pushes for key FDA clearances that will determine your product's market access. Prioritise your cash runway and regulatory milestones now to avoid operational disruptions.
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1 source · 13 Aug 2026
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