Mednition's AI-powered solution, KATE Sepsis, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The FDA designation and the performance of KATE Sepsis signal a transformative step in early sepsis recognition, with potential widespread implications for healthcare delivery, especially in emergency settings.

Why it’s notable:

• Sepsis is a critical and life-threatening condition,it is the leading cause of death in U.S. hospitals. It is also the primary cause of hospital readmissions and incurs the highest costs for hospitalisations. This designation recognises Mednition's KATE Sepsis as a significant advancement in the early detection of sepsis. This is pivotal, as the  complexity in managing sepsis stems from difficulties in early detection, where a delay of even a few hours in treatment can lead to heightened morbidity and mortality rates.

• KATE Sepsis introduces novel and breakthrough technology, demonstrating the potential to revolutionise early sepsis detection. The solution has shown an impressive improvement of up to 118% in early sepsis detection at Emergency Department (ED) Triage compared to standard screening protocols, addressing a critical need in the timely identification and treatment of sepsis.

Industry Implications: 

• The breakthrough achieved by KATE Sepsis in improving sensitivity without sacrificing specificity addresses a significant challenge in the adoption of AI for sepsis detection. KATE Sepsis predictions have a higher sensitivity with a 74% improvement for sepsis, 80% for severe sepsis, and 118% for septic shock when compared to the standard screening algorithm. This represents a notable advancement, potentially overcoming historical challenges related to false positive rates and alert fatigue.

• The FDA Breakthrough Device Designation highlights the commitment of Mednition to advancing equitable care and reducing risks for patients. By enhancing early detection capabilities with KATE Sepsis, the industry can expect improvements in patient outcomes, reduced mortality rates, and more effective and timely treatment for individuals at risk of sepsis.

Read the news story here.