Beckman Coulter Receives CE Mark
Analysis based on 7 articles · First reported Apr 13, 2026 · Last updated Apr 13, 2026
The approval of the Access MeMed BV assay by Danaher Corporation — Beckman Coulter is expected to positively impact the diagnostics market by offering a faster and more accurate method for differentiating bacterial and viral infections. This innovation could lead to significant cost savings for European healthcare systems, potentially reducing unnecessary admissions and antibiotic use, which benefits both Danaher Corporation — Beckman Coulter and its parent company Danaher Corporation.
Danaher Corporation — Beckman Coulter Diagnostics, a subsidiary of Danaher Corporation, has received CE 2797 mark under IVDR for its Access MeMed BV assay. This approval allows for the widespread availability of a high-throughput host-response test in Europe, which can differentiate between bacterial and viral infections in approximately 20 minutes. The Access MeMed BV assay, developed in partnership with MeMed, is validated for use on Danaher Corporation — Beckman Coulter's DxI 9000 and Access 2 immunoassay analyzers. Economic modeling suggests that the adoption of this assay could reduce up to €80 million in avoidable costs across European healthcare systems by decreasing unnecessary admissions and diagnostic testing. This development is poised to enhance clinical decision-making, curb unnecessary antibiotic use, and advance antimicrobial stewardship initiatives.
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