FDA De Novo approval for Sepsis ImmunoScore, an artificial intelligence/machine learning software as a medical device (AI SaMD) to guide rapid diagnosis and prediction of sepsis.= Prenosis Inc.,

Prenosis, Inc., an artificial intelligence company enabling precision medicine in acute care, announced the FDA has granted marketing authorization for the Sepsis ImmunoScore using the De Novo pathway.

The Sepsis ImmunoScore is 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, an extremely complex condition that is difficult to diagnose early and has been a decades-long challenge for the U.S. healthcare system.

Leveraging a combination of biomarkers and clinical data through AI, the Sepsis ImmunoScore aids in the risk assessment for presence of or progression to sepsis within 24 hours of patient assessment in the Emergency Department or hospital. By leveraging 22 diverse parameters, the Sepsis ImmunoScore holistically evaluates the patient’s biological status to output a risk score and four discrete risk categories; it is not an alert system. These 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). This combination of both diagnostic and predictive information had never previously been available in a legally marketed device for sepsis.

“FDA authorization of a sepsis diagnostic tool with significant predictive power is a landmark event for people that could ever be at risk of sepsis at some point in their lives,” said Bobby Reddy, Jr, Ph.D., Prenosis Co-Founder and CEO. “Until now, there was no other FDA authorized AI diagnostic for sepsis, which is why the Sepsis ImmunoScore had to be granted marketing authorization through the De Novo pathway. FDA authorization offers yet another important piece of evidence of the potential of the Sepsis ImmunoScoreTM to improve care.”

The Sepsis ImmunoScore’s software is integrated directly into hospital Electronic Medical Records, making it easily accessible to clinicians. An intuitive display reveals how each of the individual patient’s parameters was used to calculate their final sepsis score. This transparent look into the model is critical to build trust and intuition with clinicians and to enable a true clinician-AI partnership, which facilitates faster treatment decisions, improved outcomes, quality metrics, and better hospital financials.