In vitro diagnostics company Accelerate Diagnostics, Inc. (NASDAQ: AXDX) announced on Monday that the US Food and Drug Administration granted 510(k) clearance for its Accelerate Arc system and BC kit.

This platform automates positive blood culture sample preparation for use with Bruker's MALDI Biotyper CA System and Sepsityper software.

Designed for clinical labs, the system streamlines microbial identification, bypassing the need for overnight culture methods. This reduces wait times for results, crucial in sepsis treatment. Accelerate Arc leverages Bruker's reference library for rapid identification, complementing the company's future WAVE system for antibiotic susceptibility testing.

Faster results improve patient outcomes, lower antimicrobial resistance and reduce hospital costs. Additionally, Accelerate Arc replaces overnight subculture and labour-intensive Laboratory Developed Tests, meeting regulatory pressures for FDA-cleared devices.