Mednition Gains Breakthrough Device Designation for Early Sepsis Detection

Mednition has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for KATE Sepsis, a tool to help improve early spesis detection.
 
A life-threatening condition, sepsis is the leading cause of death in U.S. hospitals, the main cause of readmissions, and tops in hospitalization costs. The difficulty of treating sepsis arises from challenges in early detection, where even a few hours of delay in the treatment can result in increased morbidity and mortality.¹
 
“We are deeply honored to receive the FDA Breakthrough Device Designation for KATE Sepsis. This recognition underscores our commitment to advancing equitable care, improving patient outcomes, and reducing risk for patients,” Mednition CEO Steven Reilly said. “We believe every second counts in the fight against sepsis. KATE Sepsis represents a significant leap forward in detecting this life-threatning condition earlier and enabling clinicians to provide more effective and timely treatment.”
 
Artificial intelligence-powered KATE Sepsis has achieved this designation by introducing technology that could potentially revolutionize early sepsis detection. KATE Sepsis demonstrated the ability to improve early detection of sepsis at emergency department (ED) triage over standard screening protocols by up to 118%.  KATE Sepsis achieved this marked improvement at ED triage, before any laboratory diagnostic results are available.
 
The challenge in using AI for sepsis detection involves demonstrating high sensitivity without sacrificing specificity, which can lead to dramatic increases in false positive rates and alert fatigue. 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 sensitivity improvement is achieved without a decrease in specificity, which is 95% for KATE Sepsis. 
 
“The industry has invested deeply in building algorithms to advance early sepsis detection. However, the subtle and heterogeneous symptoms of the onset of the disease, with quick progression to life-threatening stages, has challenged researchers for decades in finding solutions with both high sensitivity and high specificity,” Mednition President Christian Reilly stated. “Expanding our KATE AI platform, already proven effective in detecting high-risk patients, to now also signal risk of sepsis is a natural extension and perfect use case for our clinical AI.” 
 
Mednition was founded in 2014 with a vision to transform healthcare by combining the power of EHR-integrated artificial intelligence and clinical expertise to address critical challenges in the healthcare industry. KATE AI, the company’s flagship solution, is designed specifically to empower emergency nurses, reduce clinical risk, and improve the quality of care. The company is funded by private investors and major healthcare financial institutions, including Concord Health Partners (AHA Innovation Development Fund LP) and Wildcat Capital Management. The company is based in Burlingame, Calif. 

Reference 
¹ Sepsis Alliance. Sepsis Fact Sheet. 2023. https://www.sepsis.org/education/resources/fact-sheets/