Accelerate Diagnostics Submits WAVE System and Gram-Negative Positive Blood Culture Menu to the FDA for 510(k) Clearance
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Accelerate Diagnostics has submitted its WAVE system and gram-negative positive blood culture test kit to the FDA for 510(k) clearance. The system aims to provide rapid antimicrobial susceptibility testing in approximately 4.5 hours, potentially improving patient outcomes in sepsis treatment by enabling faster, targeted antimicrobial therapy.
March 21, 2025 | 6:15 pm
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Company seeks 510(k) clearance for WAVE system, which could provide faster sepsis diagnostic results and potentially expand market opportunity
FDA submission represents significant progress for the company's diagnostic technology, potentially opening new revenue streams and demonstrating technological advancement
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 100