Accelerate Diagnostics
Accelerate Diagnostics, Inc. is an in vitro diagnostics company, which engages in the provision of solutions that improve patient outcomes and lower healthcare costs through the rapid diagnosis of serious infections. It also focuses on developing and commercializing innovative instrumentation for the rapid identification and antibiotic susceptibility testing of infectious pathogens. The firm's products include Accelerate Pheno and Accelerate PhenoTest. The company was founded in 1982 and is headquartered in Tucson, AZ.
Clinical Trials
4
0 active
Approvals
0
Total approvals
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Regulatory bodies
Founded
N/A
Completed
2
50.0%
Unknown
1
25.0%
Withdrawn
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25.0%
No approval data available
- Accelerate Diagnostics has submitted its WAVE system and gram-negative test kit to the FDA for 510(k) clearance, designed to deliver antimicrobial susceptibility results in just 4.5 hours. - The technology aims to address the global sepsis crisis affecting 49 million people annually with 11 million deaths, including 1.32 million attributed to antimicrobial resistance. - If approved, the WAVE system could significantly improve patient outcomes by enabling same-shift targeted antimicrobial therapy while helping combat resistance and reducing the $62 billion annual cost burden of sepsis in the US healthcare system.
- The FDA has cleared Accelerate Diagnostics' Accelerate Arc system for rapid microbial identification from positive blood cultures, aiding in sepsis management. - The system automates sample preparation for Bruker's MALDI Biotyper, reducing the need for overnight cultures and accelerating result delivery. - By providing rapid identification and antibiotic susceptibility testing, the system enables clinicians to optimize antibiotic therapy sooner, improving patient outcomes. - The Accelerate Arc system is designed to replace laborious lab-developed tests, offering clinical laboratories an automated, FDA-cleared alternative.
