10:10 AM EDT, 09/30/2024 (MT Newswires) -- Accelerate Diagnostics ( AXDX ) said Monday that the US Food and Drug Administration has granted 510(k) clearance to its Accelerate Arc system and BC kit, an automated platform for positive blood culture sample preparation, to diagnose sepsis and antimicrobial resistance.

The system, which is used with Bruker's MALDI Biotyper CA System and MBT-CA Sepsityper software extension, streamlines workflows by providing rapid microbial identification without the need for overnight culture methods, the company said. This advancement is critical for improving patient outcomes in sepsis management, it added.

Shares of the company were down 1.7% in early trading Monday.

Price: 1.73, Change: -0.03, Percent Change: -1.70