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Article originally published February 2026 […]

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Sepsis ImmunoScore®

First-ever FDA authorized AI sepsis diagnostic tool with powerful diagnostic and predictive capabilities

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Axios, a widely respected outlet known for its national reach and authoritative reporting on health and technology, profiled Prenosis and its FDA-authorized Sepsis ImmunoScore™, the groundbreaking AI-powered tool revolutionizing sepsis prediction and diagnosis with advanced data-driven insights:

The first AI-powered tool for diagnosing a leading cause of death from hospital-related infection was cleared by the FDA yesterday, according to its developer.

Why it matters: Sepsis, an extreme immune system reaction to infection, contributes to at least 350,000 deaths in the U.S. each year and is hard to diagnose. Roughly 1 in 3 patients who die in the hospital had sepsis during their hospitalization, per the CDC.

Driving the news: The new FDA-cleared tool from Prenosis leverages info from 22 different parameters, including blood analysis, to predict the likelihood of a patient developing sepsis according to four risk categories.

Those results are provided in a patient’s electronic health record, with an explanation of how the parameters were used to calculate a risk score. That transparency is “critical” to building clinicians’ trust in the AI tool, the company said in a release.

Prenosis said it developed the tool using a biobank of more than 100,000 blood samples.

Read the article on the Axios website.