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24th June 2024  Product update: rapidmicrobiology staff writer

bioMérieux's AST System VITEK® REVEAL Achieves FDA 510(k) Clearance

  • BioMérieux's VITEK® REVEAL™ AST System, was originally developed by Specific Diagnostics
  • Now with FDA clearance, the system, reports results directly from positive blood cultures, and is part of bioMérieux's commitment to combat sepsis and Antimicrobial Resistance (AMR).
  • The system can deliver actionable results for gram-negative bacteria from positive blood cultures in 5.5-6 hours, enabling same-day treatment for bacteremic sepsis patients.

bioMérieux's VITEK® REVEAL™ AST System, that reports results directly from positive blood cultures, has received U.S. Food and Drug Administration (FDA) 510(k) clearance.

As part of its commitment to combat sepsis and AMR (Antimicrobial Resistance), in 2022 bioMérieux acquired Specific Diagnostics, a U.S. based company that had developed an AST system now called VITEK® REVEAL™. The instrument seamlessly integrates into bioMérieux’s unique and comprehensive portfolio of diagnostic solutions to address bloodstream infections and sepsis.

The modular VITEK® REVEAL™ AST system can deliver actionable results for gram-negative bacteria directly from positive blood cultures in an average of 5.5-6 hours enabling same-day treatment decision-making for patients suffering from bacteremic sepsis.

VITEK® REVEAL is fully aligned with bioMérieux’s priority to provide innovative diagnostics to support antimicrobial stewardship. By integrating this advanced technology in bioMérieux’s portfolio, we are increasing the ability of laboratories to deliver AST results as soon as possible, especially in cases of critical bacteremia-associated  sepsis, which require urgent and appropriate treatment.” added Dr. Charles K. Cooper, Executive Vice President, Chief Medical Officer.

The FDA 510(k) clearance allows the commercialization of VITEK® REVEAL™ in the United States. In August 2022, the FDA granted the system with its Breakthrough Device Designation, which is reserved for medical devices that offer significant advantages over existing cleared alternatives, for which no approved alternatives exist, and/or for which device availability is in the best interest of patients. This AST system is also CE-marked under IVDD* (reagents) and IVDR** (instrument) in Europe.

Visit www.biomerieux.com for full press release and references

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Date Published: 24th June 2024

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.

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