Accelerate Diagnostics submits WAVE system for FDA 510(k) clearance

Accelerate Diagnostics (AXDX) announced the submission of its Accelerate WAVE system and positive blood culture gram-negative test kit to the U.S. Food and Drug Administration for 510(k) clearance. “The Accelerate WAVE system is designed to provide rapid antimicrobial susceptibility testing (AST) directly from positive blood culture bottles and bacterial isolate colonies. The WAVE system is designed to deliver accurate results in an average of 4.5 hours, enabling same shift targeted antimicrobial therapy for patients with serious infections. With a user-friendly workflow, high throughput capacity, and scalable design, once approved by the FDA, the WAVE system will offer microbiology laboratories a comprehensive AST solution to meet a wide range of testing demands and hospital formulary needs,” the company stated.