August 2024—BioMérieux announced that its Vitek Reveal AST system has received FDA 510(k) clearance. The modular system can deliver actionable results for Gram-negative bacteria directly from positive blood cultures in an average of 5.5 to 6 hours, enabling same-day treatment decision-making for patients suffering from bacteremic sepsis. The system is also CE marked under the in vitro diagnostic medical devices directive and in vitro diagnostic medical devices regulation in Europe.
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