Biotech
Wednesday, April 3rd, 2024 3:16 pm EDT
Key Points
- Prenosis announces FDA approval for its AI-powered diagnostic tool for sepsis, a significant milestone in healthcare technology.
- Sepsis, a life-threatening condition resulting from extreme infection response, presents diagnostic challenges, with early detection critical due to rapid patient deterioration.
- Prenosis’ Sepsis ImmunoScore utilizes 22 parameters, employing AI to assess sepsis risk, streamlining diagnosis. Built on the Immunix platform, it integrates with electronic health records, approved through FDA’s De Novo pathway, marking a notable achievement for the Chicago-based startup.
Prenosis, a health technology company, achieved a significant milestone by obtaining approval from the U.S. Food and Drug Administration (FDA) for its artificial intelligence-powered diagnostic tool for sepsis, marking the first such approval in the field. Sepsis, a life-threatening condition resulting from the body’s extreme response to infection, poses a considerable challenge in diagnosis, with early detection being crucial for patient outcomes. Prenosis’ tool, named Sepsis ImmunoScore, utilizes 22 parameters to assess a patient’s sepsis risk, streamlining the diagnostic process by employing AI to evaluate multiple markers simultaneously. Built on Prenosis’ Immunix platform, which draws from a vast dataset of over 100,000 blood samples, Sepsis ImmunoScore integrates seamlessly into electronic health records, facilitating easy access and utilization for clinicians. The FDA’s approval through the De Novo pathway underscores the uniqueness of Prenosis’ solution, setting it apart in the market. While other organizations, like Johns Hopkins University and Epic Systems, have developed similar AI-based sepsis detection tools, Prenosis’ rigorous approach to obtaining FDA clearance underscores its commitment to safety and effectiveness. Moving forward, Prenosis plans to conduct further studies to validate the accuracy and clinical impact of Sepsis ImmunoScore, with the aim of making it available to hospitals in the U.S. and globally.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/04/03/prenosis-says-ai-tool-for-sepsis-approved-by-fda.html
