Bruker announced FDA 510(k) clearance for software, a sample‑prep process and expanded reference libraries for its MALDI Biotyper CA clinical microbiology system. The clearance covers the MBT Compass HT CA software, the MBT FAST Shuttle US IVD sample‑prep process and an expanded library that now spans 549 microbial species. Bruker said the software enables parallel data processing, improved user management and 21 CFR Part 11 support, while the automated IDealTune QC function helps maintain system performance. The company said current users can upgrade and that shipments are being prepared. The clearance extends the platform’s clinical reach and standardizes faster, higher‑confidence microbial identification for diagnostic labs.