BioMérieux: FDA clearance and CE marking for Vitek Pro, launch planned for 2027
BioMérieux announced on November 10, 2026 that it had completed the two regulatory steps required before marketing its new instrument for microbial identification and antimicrobial susceptibility testing. From 2027, the system is expected to replace the Vitek 2 and Vitek XL platforms, which are central to the group's microbiology offering.
Vitek Pro, a new pillar of the offering against antimicrobial resistance
Vitek Pro has received 510(k) clearance from the U.S. Food and Drug Administration as well as CE marking under the European regulation on in vitro diagnostic medical devices (EU 2017/746). On a single platform, the instrument identifies the microorganism responsible for an infection and measures its susceptibility to antimicrobials, in order to guide the choice of antibiotic therapy.
The group places this launch within the fight against antimicrobial resistance, which the World Health Organization classifies among the main threats to public health. According to a study published in The Lancet in 2022 and cited by the company, it was responsible for 1.27 million deaths in a single year.
Jennifer Zinn, Deputy Chief Executive Officer in charge of clinical operations, recalled the importance of this focus: "Today, with approximately 80% of our portfolio contributing to the fight against antimicrobial resistance, we remain committed to delivering solutions that help make better clinical decisions." The group also indicates that it devotes 75% of its R&D to this area.
Céline Roger-Dalbert, Deputy Chief Executive Officer in charge of research and development, explained: "With Vitek Pro, we combine decades of expertise in automated microbiology with significant innovations in workflow, software architecture, connectivity and user experience."
A two-phase rollout to replace Vitek 2 and Vitek XL
Commercialization is scheduled to begin in the first quarter of 2027 in selected regions, including the United States and certain European countries. Availability will then be progressively extended to other regions from the second quarter of 2027, with the stated objective of replacing the Vitek 2 and Vitek XL systems.
The instrument is aimed at medium- and high-volume laboratories, with a modular capacity that can be adjusted according to their needs. It succeeds the Vitek Compact Pro model, launched in 2025, within the Vitek range, and is integrated into the group's offering dedicated to the appropriate use of antibiotics.
This announcement comes a day after another FDA decision: on November 9, 2026, BioMérieux reported an authorization covering revised versions of its BioFire FilmArray gastrointestinal panels. In 2025, the group generated revenue of 4.1 billion euros, of which more than 94% was generated outside France.
