Friday, May 24, 2024

Advancing Sepsis Detection: Prenosis Secures FDA Authorization for Groundbreaking AI Sepsis ImmunoScoreTM

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The Food and Drug Administration (FDA) has granted de novo clearance to an innovative artificial intelligence (AI) tool developed by Prenosis, known as the Sepsis Immunoscore software, marking a pioneering milestone as the first FDA-authorized AI tool for sepsis detection and diagnosis. This groundbreaking AI diagnostic and predictive tool is specifically designed for early sepsis detection, a condition that poses a substantial challenge to healthcare systems worldwide due to its complex nature and the difficulty in diagnosing it promptly. The FDA’s approval of the Sepsis ImmunoScoreTM marks the first instance of an AI-based diagnostic tool for sepsis gaining marketing authorization, addressing a decades-long need for more accurate and early sepsis detection methods within the U.S. healthcare sector.

Sepsis, characterized by an overactive and detrimental response to infection, leads to significant mortality rates and imposes considerable financial burdens on healthcare systems, costing billions of dollars annually. This condition claims more lives each year than all forms of cancer combined, underscoring the urgent need for innovative solutions like sepsis detection tool the Sepsis ImmunoScoreTM. Despite the grave impact of sepsis and the urgent need for effective diagnostic tools, the path to FDA authorization for an AI diagnostic tool for sepsis was uncharted until Prenosis’ recent breakthrough.

The sepsis detection tool, Sepsis ImmunoScoreTM, leverages a sophisticated combination of biomarkers and clinical data, employing artificial intelligence and machine learning algorithms to assist healthcare professionals in assessing the risk of sepsis presence or progression within a 24-hour timeframe. This tool analyzes 22 diverse parameters to evaluate a patient’s biological status comprehensively, providing a risk score and categorizing patients into four discrete risk levels.

Prenosis Launches First FDA-Authorized AI Tool for Enhanced Sepsis Detection and Care Management

These risk levels offer insights into the patient’s likelihood of deterioration, as indicated by potential outcomes such as the length of hospital stay, in-hospital mortality, and the need for escalated care, including Intensive Care Unit (ICU) admission, mechanical ventilation, or vasopressor use. This innovative approach, which combines diagnostic and predictive capabilities, was previously unavailable in any legally marketed device for sepsis.

Bobby Reddy, Jr, Ph.D., Co-Founder and Chief Executive Officer of Prenosis, emphasized the transformative potential of the sepsis detection tool, Sepsis ImmunoScoreTM, in addressing the critical and unmet needs of individuals at risk of or suffering from sepsis. The FDA’s decision to grant marketing authorization through the De Novo pathway—a regulatory pathway for novel, low- to moderate-risk devices that lack a predicate device—reflects the uniqueness and innovative nature of the Sepsis ImmunoScoreTM. This authorization not only validates the tool’s potential to improve patient care but also highlights the significance of AI in advancing healthcare diagnostics.

The integration of the sepsis detection tool, Sepsis ImmunoScoreTM, software directly into hospitals’ Electronic Medical Records (EMRs) ensures its accessibility to clinicians, facilitating rapid and informed treatment decisions. An intuitive interface displays how each parameter contributes to the final sepsis score, fostering transparency and trust between clinicians and the AI tool and promoting a synergistic clinician-AI partnership.

Sepsis Detection

Prenosis’ FDA-Cleared Sepsis ImmunoScoreTM Elevates Precision Medicine with ImmunixTM Technology

Prenosis’ achievement is underpinned by its ImmunixTM precision medicine platform, which has enabled the development and validation of the Sepsis ImmunoScoreTM and other precision medicine tools. This platform is built on a proprietary biobank and dataset, derived from a collaboration with ten partner hospitals across the United States, containing over 100,000 blood samples from more than 25,000 patients. This extensive dataset, coupled with in-house assays and clinical data, forms the foundation for developing AI algorithms capable of identifying patterns in rapid immune response, propelling forward the precision medicine revolution in acute care.

In conclusion, the FDA authorization of the Sepsis ImmunoScoreTM represents a crucial advancement in the field of healthcare, offering new hope for improving the management and outcomes of sepsis. Through the power of AI and precision medicine, Prenosis is setting a new standard in acute care, demonstrating the potential to transform patient care with innovative diagnostics that are tailored to each individual’s unique biological profile.

 

Resource: Prenosis, April 03, 2024

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