Gradientech starts US 510(k) study for QuickMIC® at clinical sites
The diagnostics company Gradientech today announces to have started the 510(k) clinical study for the QuickMIC® system for ultra-rapid antibiotic susceptibility testing at the first two clinical sites, both well-renowned hospitals in the US.Following successful pre-clinical evaluation studies of the QuickMIC system in the US last year, and with a breakthrough device designation by the FDA, the 510(k) study of QuickMIC and its first gram-negative panel is now initiated at clinical sites in the US. The focus of the clinical study will be antibiotic susceptibility testing results for gram-