French diagnostics company bioMérieux (Euronext Paris:BIM) announced on Tuesday that it has received US Food and Drug Administration (FDA) 510(k) clearance and European IVDR CE marking for VITEK PRO, its new automated microbial identification (ID) and antimicrobial susceptibility testing (AST) platform.

The system is designed to support clinical laboratories in diagnosing infectious diseases and strengthening antimicrobial stewardship efforts.

Building on more than 35 years of ID/AST expertise, VITEK PRO combines automated workflows, digital capabilities and a broad antimicrobial testing menu. The platform enables laboratories to identify infection-causing microorganisms and determine their antimicrobial susceptibility, supporting timely clinical decisions and appropriate antibiotic selection.

Designed for medium- and high-volume laboratories, the system features scalable capacity to accommodate evolving testing requirements while improving operational efficiency and maintaining diagnostic reliability, bioMérieux said.

bioMérieux plans to begin commercial launches in selected markets, including the United States and parts of Europe, in the first quarter of 2027. Wider international availability is expected in the second quarter of 2027, as VITEK PRO progressively replaces the company's VITEK 2 and VITEK XL systems.