Forbes, a global leader in business and innovation coverage, profiled Prenosis and its groundbreaking FDA-authorized Sepsis ImmunoScore™:
The U.S. Food and Drug Administration approved an AI tool that can diagnose sepsis, Prenosis, the company behind the software, announced Wednesday, the latest in a series of agency approvals for AI diagnostic tools.
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KEY FACTS
The Sepsis ImmunoScore uses 22 diagnostic and predictive parameters to calculate the risk of a patient developing sepsis within 24 hours, a criteria combination that has “never previously been available in a legally marketed device” for the condition, according to a press release.
Prenosis spokesperson Gary Poole told Forbes the criteria includes inflammatory biomarkers, vital measurements and demographic information, among others.
The tool, which is integrated into hospitals’ electronic medical records, was built using the Chicago-based startup’s Immunix platform, which is a dataset containing more than 100,000 blood samples from more than 25,000 patients.
The Sepsis ImmunoScore was approved through the agency’s De Novo pathway, the process the FDA uses for novel medical devices.
Poole said the company plans to sell the Sepsis ImmunoScore at hospitals across the nation, adding it plans to announce a “distribution partnership with a large diagnostic company next week.”
Read the Forbes article.