Prenosis, Inc. made a significant announcement on Wednesday regarding the FDA’s marketing authorization for their AI SaMD tool called Sepsis ImmunoScore through the De Novo pathway.
The Sepsis ImmunoScore is a cutting-edge artificial intelligence/machine learning software that has been designed to aid quick diagnosis and prediction of sepsis.
It is the first AI diagnostic tool for sepsis that has received FDA marketing authorization, which is a significant milestone for the healthcare industry as sepsis is a complex condition that poses challenges for early diagnosis in the U.S. healthcare system.
Sepsis is a life-threatening medical condition that results from an infection and has high mortality rates. According to the Centers for Disease Control and Prevention, over 350,000 adults either die from sepsis during hospitalization or require hospice care annually.
Prenosis’ Sepsis ImmunoScore tool is a remarkable innovation that utilizes 22 parameters such as temperature, heart rate, and cell count to assist clinicians in evaluating a patient’s sepsis risk. Unlike traditional monitoring methods, the AI system simultaneously analyzes all these indicators to generate an overall risk score and four risk categories indicating the likelihood of patient deterioration.
Developed on Prenosis’ Immunix platform, Sepsis ImmunoScore is constructed from a dataset of over 100,000 blood samples gathered from 25,000 patients.
It is a highly effective tool that helps healthcare providers streamline patient record management. The tool is seamlessly integrated into hospital electronic health records, ensuring accessibility and utilization of Sepsis ImmunoScore within existing workflows. Additionally, clinicians have visibility into the specific parameters considered in calculating the overall risk score.
Prenosis’ spokesperson Gary Poole revealed plans to market the Sepsis ImmunoScore in hospitals nationwide and hinted at an upcoming distribution partnership with a prominent diagnostic company.
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