FDA Approves First AI-Powered Sepsis Diagnosis Tool by Prenosis

By Thea Felicity

Apr 03, 2024 01:10 PM EDT

SINGAPORE-TECHNOLOGY-HEALTHCARE-OFFBEAT — In this photo taken on October 12, 2017, Singaporean physician Calista Lim Hui Min (R) takes the pulse reading of patient Elaine Low, 35, (L) before receiving a massage by a robot masseuse at the NovaHealth traditional chinese medicine (TCM) clinic in Singapore. A robot masseuse named Emma is offering Singaporeans high-tech back rubs with a gigantic metal arm and warm silicon tips which its creators say perfectly mimic the human touch. The robot, the brainchild of local startup AiTreat, began work at a clinic in the city-state this week and performs "tui na", a type of massage practised in traditional Chinese medicine.
(Photo : ROSLAN RAHMAN/AFP via Getty Images)

In a historic milestone for healthcare innovation, the US Food and Drug Administration has granted authorization to Prenosis for its groundbreaking artificial intelligence-powered diagnostic software, marking the first-ever FDA approval of an AI tool designed to diagnose sepsis.

Prenosis announced the authorization of its AI tool for Sepsis Diagnosis and called it a major leap forward in medical technology. It offers a promising solution to the longstanding challenge of effectively identifying sepsis, a condition characterized by the body's extreme response to infection and often fatal consequences.

With sepsis claiming the lives of over 350,000 adults annually, early detection is paramount, as patients can rapidly deteriorate without timely intervention.

How Prenosis AI Tool for Sepsis Diagnosis Works

Prenosis' Sepsis ImmunoScore uses advanced AI algorithms to analyze 22 distinct parameters, including temperature, heart rate, and cell counts, providing clinicians with a comprehensive assessment of a patient's sepsis risk.

This means that Sepsis ImmunoScore combines these indicators related to sepsis into one overall risk score. It then categorizes patients based on how likely they are to deteriorate due to sepsis. This system provides healthcare professionals with valuable information that helps them make quick and well-informed decisions about patient care.

The AI-powered Sepsis diagnosis tool was developed on Prenosis' Immunix platform and is the result of extensive research and innovation, drawing from a large dataset of blood samples.

Integrated into electronic health records, the tool seamlessly fits into clinical workflows, ensuring ease of use for medical practitioners.

Per CNBC, the FDA's endorsement of Prenosis' solution via the De Novo pathway validates its groundbreaking work in AI-driven healthcare technology. As a trailblazer in AI-based sepsis diagnostics, Prenosis stands out despite similar initiatives by institutions like Johns Hopkins University and Epic Systems.

What sets Prenosis apart is its thorough approach, characterized by close collaboration with regulatory bodies and rigorous safety assessments, demonstrating its dedication to the effectiveness and safety of its technology.

Looking ahead, Prenosis plans to conduct further studies to validate the accuracy and clinical impact of Sepsis ImmunoScore, with aspirations to introduce the tool to hospitals across the United States and eventually worldwide.

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