Revolutionary Celiac Diagnosis: Alivedx announces FDA application!

Revolutionary Celiac Diagnosis: Alivedx announces FDA application!

Austria's health system is given significant technological progress, because Alivedx has announced that there is an application for a 510 (K) premarket notification for the new Mosaiq AiPlex® Zöliakie microarray at U.S. Food and Drug Administration (FDA) submitted. This state -of -the -art diagnostic instrument aims to significantly accelerate and simplify the methods for identifying celiac disease. With the development of this multiplexing test, which received IVDR CE certification in August 2024, an early diagnosis of this chronic autoimmune disease is sought that affects millions of people worldwide. The Mosaiq Aiplex CD-Assay enable results with only 20 μl of a patient sample in a single step, which significantly increases efficiency in clinical practice, such as adnkronos.com emphasized.

The MosaiQ solutions are not only designed for speed and accuracy, but also offer simplified workflow navigation for laboratories and clinics. The combination -based approach makes it possible to obtain relevant diagnostic information in just one test course, and at the same time reduces the need for extensive resources, which is of crucial importance in future -oriented health services. This innovative design reflects Alivedx's commitment to further develop the diagnostic technologies and to address the challenges in the field of autoimmune diseases globally.