BioMérieux Secures FDA Clearance and CE Marking for VITEK® PRO

bioMérieux, a leader in in vitro diagnostics, announced FDA 510(k) clearance and IVDR CE marking for its new VITEK® PRO system. This automated tool for microbial identification and antimicrobial susceptibility testing aims to bolster efforts against antimicrobial resistance. The product launch is expected in early 2027.

Antimicrobial resistance poses a major global health threat, linked to approximately 1.27 million deaths annually. Accurate testing enhances clinical decision-making and patient management. VITEK® PRO, designed for easy operation and reliability, helps laboratories identify infections and select the best antibiotic therapy efficiently.

With its scalable design, VITEK® PRO is suited for medium to high-volume labs, offering productivity gains without sacrificing diagnostic confidence. The system integrates modern digital capabilities and a comprehensive antimicrobial testing menu.