Press release summary
bioMérieux said Nov. 10 that VITEK PRO received U.S. Food and Drug Administration 510(k) clearance and CE marking under the European Union’s In Vitro Diagnostic Medical Devices Regulation. The automated system is designed to identify clinically relevant microorganisms and determine their antimicrobial susceptibility on a single platform. The company plans to begin commercial introduction in selected U.S. and European markets in the first quarter of 2027.
VITEK PRO is intended for medium- and high-volume microbiology laboratories. bioMérieux said the system offers scalable capacity, automated handling, digital workflow features and connectivity intended to support laboratory operations. The company expects VITEK PRO to progressively replace its VITEK 2 and VITEK XL instruments as the rollout expands.
Why it matters to laboratory readers
Organism identification and susceptibility testing are central to infectious disease diagnosis and antimicrobial stewardship. A combined platform could simplify worklists and capacity planning for laboratories with rising testing volumes. Before adoption, laboratories will still need to review menu coverage, performance data, validation requirements, middleware or LIS integration, training and the regional implementation schedule.
Read the original bioMérieux release.
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