Scanogen Received FDA Breakthrough Device Designation for Rapid Bloodstream Infection Assay
On October 15, 2025, Scanogen Inc., a molecular diagnostics innovator developing next-generation infectious disease detection technologies, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for its rapid assay that identifies bloodstream infection pathogens directly from patient samples.
The FDA’s Breakthrough Device designation is reserved for technologies with the potential to significantly improve the diagnosis or treatment of life-threatening or permanently debilitating conditions. This recognition will accelerate...
