Authority & Credentials
KATE Receives FDA Breakthrough Device Designation for Early Sepsis Detection
Mednition’s clinical AI earned one of the FDA’s most selective designations — reserved for technologies that may more effectively diagnose life-threatening conditions.
The designation
The U.S. Food and Drug Administration granted KATE AI Breakthrough Device Designation for early sepsis detection. The Breakthrough Devices Program is designed to expedite the development and review of devices that may provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases — in this case, sepsis at the emergency department front door.
Why it matters clinically
Sepsis is among the leading causes of in-hospital death, and outcomes hinge on how quickly treatment begins. KATE’s model identifies sepsis risk at triage, often before laboratory results are available, giving clinical teams a head start on the time-critical one-hour bundle. The FDA designation underscores both the seriousness of the problem and the clinical promise of KATE’s approach.
Backed by peer-reviewed research
Mednition’s sepsis work is documented in published research on accurate detection of sepsis at ED triage using machine learning with clinical natural language processing. KATE has supported more than 4 million patient visits across emergency departments, and Adventist Health has approved systemwide adoption of KATE to support its ED nurses.