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FAST BioMedical has completed five clinical trials across eight sites in the US and Germany, dosing over 150 patients. The company’s investigational product demonstrated precise, reproducible, accurate, and safe quantification of plasma volume and kidney function. The method provides results within clinically actionable timeframes—volume status in about 45 minutes and kidney function within approximately three hours. Performance has been independently validated by the University of Minnesota Advanced Research & Diagnostics Laboratory. Regulatory approval requires one additional pivotal trial.
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