Bruker received FDA 510(k) clearance for new MBT Compass HT CA software, MBT FAST Shuttle US IVD sample prep and an expanded reference library for its MALDI Biotyper clinical microbiology system. The package improves throughput, standardizes sample prep and increases species coverage to 549 microbial taxa. Bruker said the cleared updates support parallel data processing, 21 CFR Part 11 compliance and automated tuning for QC. The company plans ship‑ready updates and upgrade options for existing customers. The clearance boosts clinical microbiology labs’ capacity for rapid pathogen identification and could accelerate adoption of MALDI‑based workflows versus slower culture‑dependent methods.
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