Institute of Good Manufacturing Practices India®

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FDA grants de novo nod to AI tool for sepsis detection

Prenosis secured de novo clearance for a predictive tool assessing sepsis risk within 24 hours, featuring a prioritized list of influencing parameters. Sepsis, a severe infection response, claims about 270,000 lives annually, necessitating timely treatment due to varying symptoms.

Software firms and hospitals focus on early detection tools after a 2021 study revealed limitations in a widely used Epic Systems tool, prompting Prenosis to proactively seek FDA clearance. Their April 2 authorization allows their software to serve as a benchmark for other sepsis prediction tools.

The Sepsis Immunoscore evaluates four risk categories: sepsis occurrence within 24 hours, in-hospital mortality, and hospital and ICU stay lengths within 24 hours. Integrated into electronic health records, it assigns a risk score from 0-100 and ranks 22 parameters based on their contribution to increased risk.

This tool cleared via a 750-person study across three sites, underwent sub-analyses evaluating performance across gender, race, and health comorbidities. Roche Diagnostics began collaborating with Prenosis in 2020 to expand its core dataset for FDA clearance.