Automated Microbial Identification and Susceptibility System Gains FDA Clearance

27 million deaths annually. The growing challenge of diagnosing and treating resistant infections highlights the need for accurate laboratory testing to guide clinical decisions. A newly cleared and CE-marked system addresses this need by automating microbial identification and antimicrobial susceptibility testing on a single platform for routine microbiology laboratories.

bioMérieux’s VITEK PRO system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for microbial identification (ID) and antimicrobial susceptibility testing (AST). The system has also received CE marking under the European Union’s In Vitro Diagnostic Regulation (IVDR), with commercial launch expected to begin in the first quarter of 2027.

VITEK PRO is designed to identify the microorganism responsible for an infection and determine antimicrobial susceptibility using a single platform. The system is intended to help clinicians select appropriate antibiotic therapy by providing timely ID/AST results. It combines workflow automation, modern digital capabilities, flexible capacity for expansion, and a broad antimicrobial testing menu aligned with local epidemiology requirements.

The instrument is positioned for medium- and high-volume laboratories that require scalable routine microbiology testing. Following the 2025 launch of VITEK COMPACT PRO, VITEK PRO becomes the latest addition to the VITEK family. bioMérieux plans to launch in selected geographies, including the United States and some European countries, before expanding availability worldwide in the second quarter of 2027 to replace VITEK 2 and VITEK XL systems.

“Antimicrobial resistance continues to threaten the foundations of modern medicine. Rapid and accurate antimicrobial susceptibility testing is essential to ensure patients receive the most appropriate treatment as early as possible,” said Céline Roger-Dalbert, Executive Vice President, Research and Development, bioMérieux.

“With VITEK PRO, we are bringing together decades of expertise in automated microbiology with significant innovations in workflow, software architecture, connectivity, and user experience. This new platform reinforces bioMérieux's commitment to supporting healthcare professionals worldwide in the fight against antimicrobial resistance,” added Roger-Dalbert.