FDA Grants Breakthrough Status to Scanogen’s Rapid Sepsis Diagnostic Test
Scanogen Inc. has received FDA Breakthrough Device Designation for its rapid bloodstream infection assay that can identify sepsis-causing pathogens in just two hours. The technology represents a significant advancement over current methods that typically require one to five days for results, according to company reports.
FDA Recognition for Rapid Sepsis Diagnostic
Scanogen Inc., a molecular diagnostics company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its rapid assay designed to identify bloodstream infection pathogens directly from patient samples, according to company announcements.