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.
Cereno Scientific's Phase IIb trial of CS1 in PAH approved by US FDA
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Mirum Pharmaceuticals to acquire Bluejay Therapeutics for HDV treatment
PureTech clears key FDA milestone for Phase 3 development of deupirfenidone
J & D Pharmaceuticals' investigational therapy for HCC receives US FDA Orphan Drug Designation
FDA lifts partial clinical hold on Vanda Pharmaceuticals' tradipitant for motion sickness
TransThera publishes clinical results from US-based Phase 2 trial of tinengotinib in CCA
Hope Medicine wins FDA Fast Track Designation for HMI-115 in endometriosis
MED-EL cochlear implant FDA approved for children 7 months and older