French diagnostics company bioMérieux (Euronext Paris:BIM) announced on Friday that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its VITEK REVEAL AST System.
VITEK REVEAL delivers rapid antimicrobial susceptibility testing (AST) results directly from positive blood cultures, enabling same-day treatment decisions for patients with bacteremic sepsis. The system is designed to improve patient care and combat antibiotic resistance, a global health threat.
bioMérieux acquired VITEK REVEAL's developer, Specific Diagnostics, in 2022. The modular system provides results for gram-negative bacteria in an average of 5.5 to 6 hours.
VITEK REVEAL received FDA Breakthrough Device Designation in August 2022 and is CE-marked in Europe.
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