Health technology innovator Prenosis has achieved a life-changing milestone with the U.S. Food and Drug Administration (FDA) granting approval to its groundbreaking AI-powered diagnostic tool for sepsis.
Addressing a Deadly Threat
Sepsis poses a grave threat, with over 350,000 adult fatalities attributed to the condition annually, as per the Centers for Disease Control and Prevention.
Prompt diagnosis is crucial as sepsis can rapidly escalate. However, identifying sepsis accurately has remained a daunting challenge in healthcare.
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Introducing Sepsis ImmunoScore
The wonders that AI can accomplish are beyond something unimaginable. Lately, it's been a big help for the healthcare sector which is struggling to keep up with advanced technology.
Prenosis' pioneering solution, Sepsis ImmunoScore, utilizes 22 distinct parameters, including temperature, heart rate, and cell counts, to assess a patient's sepsis risk comprehensively.
Unlike traditional methods that require clinicians to monitor these parameters individually, Sepsis ImmunoScore leverages AI to analyze all markers simultaneously. The tool furnishes an overall risk score and four risk categories, streamlining the diagnostic process for healthcare providers.
AI-Powered Diagnostic Tool For Sepsis is Accurate
Developed on Prenosis' Immunix platform, Sepsis ImmunoScore draws from a vast dataset comprising over 100,000 blood samples from 25,000 patients. This extensive data foundation ensures the tool's accuracy and reliability.
Integrated seamlessly into electronic health records, Sepsis ImmunoScore simplifies usage and accessibility for clinicians. It provides a transparent display showcasing the parameters used to calculate the risk score, enhancing transparency and trust in the diagnostic process.
FDA Approval and Regulatory Compliance
Prenosis' approved diagnostic tool is something that we haven't seen before. It is secured through the FDA's De Novo pathway.
While other organizations have developed similar AI-driven sepsis diagnostic tools, Prenosis stands out as the first to receive FDA approval.
With FDA clearance obtained, Prenosis is poised to roll out Sepsis ImmunoScore to hospitals across the United States and globally. The company intends to conduct further studies to validate the tool's accuracy and assess its impact on clinical decision-making.
Prenosis' revolutionary AI diagnostic tool for sepsis ushers a new era in healthcare, offering clinicians a powerful tool to combat this life-threatening condition.
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Bejing added that the draft rule also held big importance when it comes to the ethical standards in the medical field.
