Prenosis, a health technology company, revealed that their artificial intelligence-powered diagnostic tool for sepsis has gained approval from the U.S. Food and Drug Administration (FDA) on Wednesday, April 3rd.
Sepsis, a condition marked by the body’s extreme response to infection, poses a significant challenge in diagnosis and treatment, often resulting in fatalities. According to data from the Centers for Disease Control and Prevention, over 350,000 adults suffer fatal outcomes or are directed to hospice care due to sepsis annually, underscoring the urgent need for improved diagnostic capabilities.
Prenosis’s Approach to Sepsis Detection
Prenosis’ innovative solution, known as Sepsis ImmunoScore, was given the green light through the FDA’s De Novo pathway, marking a notable milestone as no similar tool had been approved before.
The Sepsis ImmunoScore tool utilizes a comprehensive approach, analyzing 22 distinct parameters such as temperature, heart rate, and cell counts to assist healthcare providers in evaluating a patient’s risk of sepsis. Traditionally, clinicians have had to monitor these parameters individually, but Prenosis’ AI-driven system streamlines this process by simultaneously assessing all markers to generate an overall risk score.
Furthermore, the tool categorizes patients into four risk groups, providing valuable insights into the likelihood of clinical deterioration. Built on Prenosis’ Immunix platform, which draws from a vast dataset comprising over 100,000 blood samples from 25,000 patients, the Sepsis ImmunoScore integrates seamlessly into electronic health records, ensuring accessibility and ease of use for clinicians.
Other AI-based Solutions
While Prenosis celebrates its pioneering achievement, it’s important to note that other organizations have also ventured into the development of AI-based sepsis diagnostic tools.
- Johns Hopkins University:
- Introduced an AI system for early detection of sepsis symptoms.
- Published impressive results in Nature Medicine in 2022, demonstrating early detection hours before conventional methods.
- Epic Systems:
- Developed an AI-powered sepsis prediction tool.
- Faced criticism for predictive accuracy, with a 2021 study in JAMA Internal Medicine highlighting its poor prediction capabilities.
- Responded to criticisms by citing improvements in sepsis mortality rates.
- Reportedly overhauled its sepsis model to enhance performance, according to Stat News.
In contrast, Prenosis opted for a meticulous approach, prioritizing FDA approval before bringing its product to market.
Despite the tool being ready approximately three years ago, the company remained steadfast in its commitment to regulatory compliance and safety. This approach aligns with the FDA’s updated guidance, issued in September 2022, which emphasizes the importance of official authorization for software analyzing patient-specific medical data to detect life-threatening conditions like sepsis. Prenosis invested around 18 months in demonstrating the safety and efficacy of Sepsis ImmunoScore to the FDA, a process culminating in the recent approval.
Prenosis intends to proceed with further studies to validate the the tool’s accuracy and assess its impact on clinical decision-making. Having obtained FDA approval, the company is now prepared to introduce Sepsis ImmunoScore to hospitals across the United States, with plans for global expansion in the pipeline.
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