Business
iMDx Prepares for U.S. Commercial Launch of GraftAssureDx as Clinical Trial Nears Completion
GraftAssure™ technology adoption further broadens with 20 global transplant centers engaged by year-end 2025, including first Canadian siteGraftAssureDx™ FDA IVD approval application 95% complete at year-end; expect full submission in coming weeksAccelerating planned UK CE mark and EU IVDR submission to first half 2026, following successful TÜV SÜD ISO 13485 stage 1 & 2 audit completions in Q4 2025Strong engagement from clinical community on GraftAssureCore™ kidney registry with 17 U.S. transpla
About this update from Insight Molecular Diagnostics Inc.
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