bioMérieux VITEK PRO System for Microbial Identification and Susceptibility Testing Cleared by the FDA: U.S. Launch Planned From the First Quarter of 2027, Replacing VITEK 2 and XL
The U.S. Food and Drug Administration has granted 510(k) clearance to bioMérieux VITEK PRO system, which has also received CE marking under the European Union In Vitro Diagnostic Regulation. VITEK PRO is an automated system for microbial identification and antimicrobial susceptibility testing.
The company says VITEK PRO will replace the VITEK 2 and VITEK XL systems. It follows the 2025 launch of VITEK COMPACT PRO and is the latest addition to the VITEK family.
On commercial plans, the company says it will begin the launch in the first quarter of 2027 in selected geographies, including the United States and some European countries.
This report covers the clearance and launch facts only and offers no individual treatment advice.
Published by GSM · USA (original Chinese edition)
Photo: 食品药品监督固定图库（GSM asset-packs）
CDC Updates Measles Data on November 6: 5,182 Confirmed Cases in 2026 as of November 5, With 43 New Outbreaks and 96 Percent of Cases Outbreak Associated2026-11-10
Bechtel Medical Wound VOX Receives FDA 510(k) Clearance: The First Cleared System Combining Negative Pressure and Topical Oxygen Therapy, With a Limited Release in December2026-11-10