- On Wednesday, Prenosis unveiled its AI-driven sepsis diagnostic tool, which has gained clearance from the U.S. Food and Drug Administration.
- Sepsis arises from an exaggerated immune response to an infection, posing a significant diagnostic challenge.
- Prenosis’ innovative solution, named Sepsis ImmunoScore, was sanctioned via the FDA’s De Novo pathway, marking a pioneering approval in this domain.
The pioneering health tech firm, Prenosis, made headlines by introducing its AI-powered diagnostic tool for sepsis, becoming the inaugural recipient of FDA approval for such a system.
Sepsis, characterized by a hyperactive immune response to infection, is a grave condition claiming over 350,000 adult lives annually either during hospitalization or upon discharge to hospice, as per the Centers for Disease Control and Prevention. The diagnostic complexity of sepsis underscores the criticality of early identification, given the rapid patient deterioration associated with the condition.
Sepsis ImmunoScore, Prenosis’ cutting-edge tool, leverages 22 distinct parameters encompassing vital signs and cell counts to aid healthcare providers in assessing sepsis risk comprehensively. Unlike conventional monitoring methods that require individual parameter assessment, Prenosis’ AI solution concurrently evaluates all markers, generating a holistic risk score and four risk categories indicative of patient deterioration likelihood.
The development of Sepsis ImmunoScore was facilitated by Prenosis’ Immunix platform, underpinned by a vast dataset comprising 100,000 blood samples from 25,000 unique patients.
This user-friendly tool seamlessly integrates into electronic health records, streamlining patient record management for clinicians. By embedding Sepsis ImmunoScore into existing workflows, Prenosis ensures ease of accessibility and utilization. Clinicians are provided with a detailed breakdown of the parameters contributing to the overall risk score.
Securing approval through the FDA’s De Novo pathway signifies a significant milestone for Prenosis, positioning the Chicago-based startup as a trailblazer in the healthcare AI landscape.
While Prenosis leads the FDA-approved AI sepsis diagnostic tool sector, various entities have developed similar solutions. Johns Hopkins University, for instance, has engineered an AI system aimed at expedited sepsis symptom identification, outperforming traditional methods by detecting sepsis six hours earlier, as per a 2022 Nature Medicine study.
Epic Systems, a prominent healthcare software provider, has also ventured into AI-powered sepsis prediction. However, criticisms surrounding the model’s efficacy have surfaced, prompting the company to revamp its approach to enhance performance, as reported by Stat News.
Prenosis emphasized the importance of FDA clearance before commercialization, highlighting a commitment to safety and regulatory compliance. The company’s dedication to demonstrating Sepsis ImmunoScore’s safety and efficacy over an 18-month period underscores its conscientious approach.
With FDA approval secured, Prenosis plans to conduct further studies to validate the tool’s accuracy and impact on clinical decision-making. The company aims to introduce Sepsis ImmunoScore to U.S. hospitals initially, with global expansion on the horizon.
