Accelerate Diagnostics Stock Down Despite FDA Clearance for Arc System
Accelerate Diagnostics, Inc. (AXDX) has secured FDA 510(k) clearance for its Accelerate Arc system and BC kit, designed for use with Bruker's MALDI Biotyper CA system (MBT-CA System) and MBT-CA Sepsityper software extension.Accelerate Diagnostics' automated platform simplifies the preparation of positive blood culture samples for direct microbial identification using Bruker's MBT-CA system, removing the overnight culture requirement. The Arc system reduces wait times for critical diagnostic results, which i ...