FDA Approves AI Device Used to Predict and Diagnose Sepsis

April 3, 2024
The device is the first of its kind to be approved and should help to curb the impact of sepsis, which kills millions of people each year

The FDA has granted marketing authorization for the Sepsis ImmunoScore, “an artificial intelligence/machine learning software as a medical device (AI SaMD) to guide rapid diagnosis and prediction of sepsis. This signifies the first-ever FDA marketing authorization of an AI diagnostic tool for sepsis.”

The Sepsis ImmunoScore uses 22 parameters to “evaluate the patient’s biological status to output a risk score and four discrete risk categories” for sepsis. The resulting risk categories “correlate to a patient’s risk of deterioration, represented by length of stay in the hospital, in-hospital mortality, and escalation of care within 24 hours (ICU admission, mechanical ventilation placement, and/or vasopressor use).”

The Sepsis ImmunoScore is “integrated directly into hospital electronic medical records” and breaks down a patient’s risk score by each parameter.

The device was built using Prenosis’ Immunix precision medicine platform, which built a “proprietary biobank and dataset consisting of more than 100,000 blood samples from over 25,000 patients housed in Prenosis’ Biological Safety Level 2 lab in Chicago.” These were used to develop AI algorithms to “elucidate patterns in rapid immune response” that result in sepsis.

Sepsis, “which occurs when a person has an overactive response to an infection, costs the U.S. healthcare system billions of dollars and kills millions of people every year – more than all cancers combined.”

PR Newswire has the release.