December 2025—Bruker announced that its MALDI Biotyper CA system received expanded clearance from the FDA. The clearance includes the MBT Compass HT CA software and MBT Fast Shuttle US IVD as well as an expansion of the FDA-cleared reference library.
The MBT Compass HT CA software now offers enhanced performance, including parallel data processing, improved user management, and support for 21 CFR Part 11 compliance. It also features IDealTune, an automated tuning function that maintains optimal system performance by continuously monitoring Bruker’s US IVD Bacterial Test Standard quality control results.
The MBT Fast Shuttle US IVD is designed to accelerate the drying and matrix crystallization process, reducing sample preparation time. It also standardizes sample preparation and improves sample prep quality.
The FDA-cleared reference library now includes reference spectra of 549 clinically validated microbial species in 437 groups, covering Gram-positive and Gram-negative bacteria, anaerobes, and yeasts. The system also includes more than 3,400 nonclinically validated species.
Bruker, 978-663-3660