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FDA Grants Breakthrough Device Designation to KATE AI for Pioneering Early Sepsis Detection

Tuesday, November 14, 2023

Mednition, a leader in clinical artificial intelligence (AI) healthcare solutions, made an announcement today regarding the Breakthrough Device Designation received by KATE Sepsis from the U.S. Food and Drug Administration (FDA). This recognition highlights the significant progress made by the AI-powered solution in early sepsis detection. Sepsis, a life-threatening condition, is the leading cause of death, readmissions, and hospitalization costs in U.S. hospitals. The challenge in treating sepsis lies in timely detection, as even a slight delay in intervention can result in increased morbidity and mortality.

KATE Sepsis earned the Breakthrough Device Designation by introducing innovative technology set to revolutionize early sepsis detection. Notably, KATE Sepsis demonstrated an impressive improvement of up to 118% in early sepsis detection at the Emergency Department (ED) Triage compared to standard screening protocols. This improvement occurred at the ED triage stage, before any laboratory diagnostic results became available.

While the industry has invested significantly in developing algorithms for early sepsis detection, the complexity of the disease's onset symptoms and its rapid progression to life-threatening stages have posed challenges for researchers for decades. The Breakthrough Device Designation for this clinical AI technology marks a new era in early sepsis recognition, promising to bring about a substantial positive impact for frontline nurses and the patients they serve in hospitals.


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