France-based in vitro diagnostics company bioMérieux has received the US Food and Drug Administration (FDA) 510(k) clearance for its VITEK COMPACT PRO system.
The new VITEK COMPACT PRO system is designed for microorganism identification (ID) and antibiotic susceptibility testing (AST) to tackle antimicrobial resistance (AMR).
It helps clinical laboratories in diagnosing infectious diseases and industrial laboratories in identifying contaminants to enhance consumer safety.
bioMérieux intends to commercially launch the VITEK COMPACT PRO initially in select countries, with plans to expand worldwide in the second quarter of this year.
bioMérieux clinical operations executive vice president Jennifer Zinn said: “For decades, bioMérieux has been an industry leader in microbiology innovation.
“With the introduction of VITEK COMPACT PRO, we are continuing this journey and delivering on the specialized needs of our customers – supporting laboratories with simplified, efficient workflows and the latest technology to optimize their experience.
“bioMérieux continues to strengthen our comprehensive AMR/AMS offer and reinforce our commitment to provide next-generation ID/AST systems to healthcare and laboratory professionals around the world.”
The VITEK COMPACT PRO system aims to address the AMR challenges by providing advanced diagnostic capabilities.
The system integrates the latest diagnostic technology with the benefits of its predecessor, VITEK 2 COMPACT.
Its ergonomic design and simplified workflow improve user experience and efficiency, reducing the time laboratory technicians spend on sample loading and processing.
The system provides rapid routine ID/AST results and accurate diagnostics insights.
It delivers effective workflows and is suited for small and medium-sized laboratories, facilitating their transition from manual workflows to automation.
VITEK COMPACT PRO can be used for routine pathogen identification to ensure the quality and safety of food, pharmaceutical, and cosmetic products.
bioMérieux research and development executive vice president Céline Roger-Dalbert said: “As a leader in the fight against AMR, bioMérieux continuously innovates by developing and renewing its key diagnostic solutions.
“VITEK COMPACT PRO delivers fast, accurate and reproducible results comparable to VITEK 2 and VITEK 2 COMPACT systems.
“The ergonomic features, a new intuitive user interface, and updated software with one of the most comprehensive knowledge databases make VITEK COMPACT PRO highly appealing to both clinical and industrial laboratories.”
