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Insight Molecular Diagnostics Completes Key Milestones Advancing GraftAssureDx Toward FDA Submission
Globenewswire· 2026-03-03 13:00
NASHVILLE, Tenn., March 03, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc. (Nasdaq: IMDX) ("iMDx") today announced that in February the company completed several major milestones to support the GraftAssureDx™ test kit clinical trial for its planned in vitro diagnostic (IVD) De Novo submission to the U.S. Food and Drug Administration (FDA) and also received its ISO 13485 certification. Beginning in 2026, iMDx seeks to deliver the industry-leading molecular diagnostic test kit for clinical use th ...