The FDA has approved an AI tool for sepsis by the company Prenosis.

Prenosis Receives FDA Approval for AI Tool to Detect Sepsis

The health technology company Prenosis has made significant strides with its artificial intelligence-powered diagnostic tool for sepsis. On Wednesday, the company announced that their tool, Sepsis ImmunoScore, has received approval from the U.S. Food and Drug Administration (FDA). Sepsis, a life-threatening condition that arises from the body’s extreme response to an infection, claims the lives of over 350,000 adults annually in the United States alone. Early detection of sepsis is crucial as the condition can rapidly deteriorate. Prenosis’ innovative tool uses 22 different parameters to help healthcare providers assess a patient’s risk of sepsis in a comprehensive manner, streamlining the diagnostic process.

Developed using Prenosis’ Immunix platform, Sepsis ImmunoScore is based on a vast dataset of more than 100,000 blood samples from 25,000 patients. The AI tool integrates seamlessly into electronic health records, allowing clinicians to access and manage patient information efficiently. By providing clinicians with an overall risk score and categorizing patients based on their risk of deterioration, Sepsis ImmunoScore offers a valuable resource in the fight against sepsis.

Prenosis’ successful FDA approval under the De Novo pathway marks a significant achievement for the company, positioning them as pioneers in AI-driven sepsis diagnostics. While other organizations have also developed AI solutions for sepsis detection, Prenosis’ approach stands out for its thorough validation process and commitment to regulatory compliance. By working closely with the FDA to demonstrate the safety and efficacy of Sepsis ImmunoScore, Prenosis has set a high standard for future AI-based medical technologies.

In light of the evolving regulatory landscape, with the FDA emphasizing the importance of authorization for software detecting life-threatening conditions like sepsis, Prenosis’ proactive approach to securing approval reflects a dedication to patient safety. Moving forward, the company plans to conduct further studies to showcase the tool’s accuracy and impact on clinical decision-making. With the FDA’s endorsement in hand, Prenosis is poised to introduce Sepsis ImmunoScore to hospitals across the United States and eventually expand its reach worldwide, offering healthcare providers a cutting-edge tool in the battle against sepsis.

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