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The Sepsis ImmunoScore is indicated as follows: The Sepsis ImmunoScore is an Artificial Intelligence/Machine Learning (AI/ML)-Based Software that identifies patients at risk for having or developing sepsis. The Sepsis ImmunoScore uses up to 22 predetermined inputs from the patient's electronic health record to generate a risk score and to assign the patient to one of four discrete risk stratification categories, based on the increasing risk of sepsis. The Sepsis ImmunoScore is intended to be used in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment for presence of or progression to sepsis within 24 hours of patient assessment. It is intended to be used for patients admitted to the Emergency Department or hospital for whom sepsis is suspected, and a blood culture was ordered as part of the evaluation for sepsis. It should not be used as the sole basis to determine the presence of sepsis or risk of developing sepsis within 24 hours.

The Sepsis ImmunoScore device is a software as a medical device intended to aid in the risk assessment for progression to sepsis for patients, 18 and older, in an emergency department or hospital. The device is intended to identify patients, who have a blood culture ordered as part of their evaluation for sepsis and who are at risk of having or developing sepsis within the next 24 hours. The software uses 22 parameters from the hospital's electronic medical record (EMR), including demographics, vitals, labs, and sepsis biomarkers, and outputs the Sepsis Patient View. The Sepsis Patient View can be viewed in the EMR system or the through a web interface and it displays both a sepsis risk score and a risk stratification category as well as other supplemental information. There are four risk stratification categories (Low, Medium, High, or Very High). The device uses an artificial intelligence/machine learning (AI/ML) based algorithm that is locked to compute the risk score and place the patient in a risk category. The Sepsis ImmunoScore is intended to be used in conjunction with other laboratory findings and clinical assessments.