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Breakthrough Device Designation Granted to KATE AI for Early Sepsis Detection

Mednition, known for its expertise in clinical artificial intelligence (AI) healthcare solutions, recently announced that KATE Sepsis has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This recognition represents a substantial advancement in early sepsis detection.

Sepsis, a critical and life-threatening condition, holds the top spot as the leading cause of mortality, hospital readmissions, and associated costs in U.S. hospitals. Detecting it promptly is a challenge, as even a short delay in treatment can lead to increased morbidity and mortality. KATE Sepsis earned its designation by introducing innovative technology capable of revolutionizing early sepsis detection. Remarkably, it demonstrated an improvement of up to 118% in early sepsis detection at Emergency Department (ED) Triage compared to standard screening protocols, achieving this milestone even before the availability of laboratory diagnostic results.

Addressing a common challenge in AI adoption for sepsis detection—finding the right balance between high sensitivity and specificity to avoid false positives and alert fatigue—KATE Sepsis predictions exhibited a 74% improvement for sepsis, 80% for severe sepsis, and 118% for septic shock compared to standard screening algorithms. Importantly, this heightened sensitivity was achieved without compromising specificity, maintaining a rate of 95% for KATE Sepsis.

Despite significant investments in algorithm development for early sepsis detection, the intricate and diverse symptoms of the disease's onset have posed a persistent challenge for researchers aiming to achieve both high sensitivity and specificity. The Breakthrough Device Designation for clinical AI technology marks a new era in early sepsis recognition, offering substantial benefits for frontline nurses and the patients they care for in hospitals.

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