AliveDx Submits 510(k) Notification to FDA for MosaiQ AiPlex Vasculitis Test

AliveDx, a global in vitro diagnostics company, has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its MosaiQ AiPlex® Vasculitis (VAS) test. The announcement was made on September 3, 2025, from the company’s headquarters in Eysins, Switzerland.

The MosaiQ AiPlex® Vasculitis test is designed to aid in the diagnosis of vasculitis, a group of rare autoimmune diseases that cause inflammation of blood vessels. By submitting the 510(k) notification, AliveDx seeks FDA clearance to market the diagnostic tool in the United States. The submission marks a significant regulatory step for AliveDx as it aims to expand its portfolio of diagnostic solutions. Further details regarding the timeline for FDA review or potential market availability were not disclosed in the announcement.

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Source: GO-AI-ne1

Date: September 3, 2025

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Mark Chiang