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Recent press, briefings and insights help you stay informed about our latest product and solution developments.
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AliveDx announces U.S. Food and Drug Administration (FDA) 510(k) submission for its MosaiQ AiPlex® Vasculitis (VAS) assay.
Eysins, Switzerland, September 2nd, 2025 AliveDx, the global in-vitro diagnostics company that aims to transform patient care, today announces that it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Vasculitis (VAS)
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AliveDx registers MosaiQ®, its Instrument for Multiplex Testing of Autoimmune Diseases, Allergies and Beyond, as a Class II Exempt Device with the U.S. Food and Drug Administration (FDA)
The MosaiQ instrument is a next-generation, continuous random-access immunoassay platform offering labs automation, simple workflows, fast, multiplexed results and actionable insights for complex-to-diagnose conditions. Eysins, Switzerland – August 25, 2025 – AliveDx, the global in-vitro diagnostics company dedicated to advancing
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MosaiQ AiPlex® Vasculitis assay, now available for clinical use in the European Union and other CE mark accepting countries.
AliveDx achieves IVDR-CE Mark for a multiplexed MosaiQ AiPlex® Vasculitis (VAS) assay, designed to advance the testing of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides and Anti-GBM (Goodpasture’s) disease and improve time to results to support diagnosis of autoimmune vasculitis. Eysins, Switzerland,
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AliveDx announces US FDA 510(k) submission for MosaiQ AiPlex® Connective Tissue Diseases (CTDplus) multiplex microarray
Eysins, Switzerland, 3 April 2025 – Today, AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Connective Tissue Diseases (CTDplus) microarray. The MosaiQ AiPlex CTDplus multiplex assay, which received
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AliveDx announces US FDA 510(k) submission for MosaiQ AiPlex® Celiac Disease (CD) multiplex microarray. The MosaiQ AiPlex CD is designed to improve the accuracy and speed of celiac disease diagnosis while simplifying laboratory workflows
Eysins, Switzerland, February 10th 2025 – AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Celiac Disease (CD) microarray. The MosaiQ AiPlex CD multiplex assay, which received IVDR-CE mark
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AliveDx Expands Autoimmune Menu with IVDR-CE Marked MosaiQ AiPlex® CTDplus Multiplex Assay to Aid in Diagnosing Systemic Autoimmune Rheumatic Diseases and Streamline Laboratory Workflow
Eysins, Switzerland February 3rd, 2025 – AliveDx announces the receipt of IVDR-CE mark for its MosaiQ AiPlex® CTDplus multiplex assay. The multiplex assay enables a syndromic approach, simplifying laboratory workflow while delivering fast, actionable results to aid clinicians and laboratorians
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AliveDx Receives IVDR-CE Mark for Multiplexed Assay to Accurately Detect Celiac Disease (CD) on the MosaiQ® System
Eysins, September 3, 2024 At AliveDx, our mission is to empower diagnostic insights, transform patient care, and innovate for life. We are excited and proud to announce AliveDx has received IVDR-CE mark certification for its multiplexed MosaiQ AiPlex™ CD microarray
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AliveDx Announces Turnkey Solution for Precise, Automated Autoimmune Diagnostics
Eysins Switzerland 29 July 2024 AliveDx, a global in vitro diagnostics company that aims to transform patient care, today announced LumiQ™ – an innovative, automated immunofluorescence assay (IFA) solution. With this portfolio expansion, AliveDx can offer customers a differentiating, turnkey
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AliveDx Receives IVDR CE Mark for Groundbreaking Microarray Immunoassay in Allergy Diagnostics
Eysins, Switzerland, 29 July 2024 AliveDx is proud to announce it has received IVDR CE mark for its groundbreaking microarray immunoassay, designed for the detection of a specific IgE directed to a protein allergen in human serum. This is the
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AliveDx receives IVDR Certification of its Manufacturing Sites in Switzerland and United Kingdom
Eysins, 6 November 2023 — AliveDx a global in vitro diagnostics company headquartered in Eysins, Switzerland, today announced it has now received IVDR Certification for both its state-of-the-art manufacturing facilities located in Eysins, Switzerland and Edinburgh, United Kingdom. AliveDx is
