Groundbreaking AI Tool Gets FDA Approval
Recently, the health tech company Prenosis unveiled its groundbreaking artificial intelligence (AI)-based diagnostic tool designed to identify sepsis, marking the first time such a tool has been approved by the U.S. Food and Drug Administration (FDA).
Sepsis, a critical condition that arises from the body’s severe response to an infection, leads to hundreds of thousands of deaths annually in hospitalized patients or those moved to hospice care. The difficulty in diagnosing sepsis early, which is crucial for effective treatment due to the rapid progression of the disease, presents a significant challenge in healthcare.
The diagnostic tool developed by Prenosis, known as Sepsis ImmunoScore, leverages AI to analyze 22 different health indicators, including vital signs and laboratory results, to evaluate a patient’s sepsis risk. This innovative approach allows for a comprehensive assessment by simultaneously considering multiple health parameters that clinicians traditionally had to monitor separately. The Sepsis ImmunoScore provides an overall risk score and categorizes patients based on their deterioration risk, enhancing the ability of healthcare professionals to make timely and informed decisions.
Developed on the Immunix platform, the tool is based on an extensive dataset comprising over 100,000 blood samples from 25,000 patients. It seamlessly integrates into electronic health records, ensuring it fits effortlessly into existing medical workflows and is straightforward for clinicians to use.
This FDA approval came through the agency’s De Novo pathway, which means it is the first of its kind to be approved. While Prenosis is the pioneer in receiving FDA approval for an AI-based sepsis diagnostic tool, other institutions like Johns Hopkins University have also developed AI systems targeting early sepsis detection, with some models reportedly identifying sepsis symptoms hours before conventional methods.
Prenosis emphasized its commitment to safety and efficacy by choosing to seek FDA approval before marketing the Sepsis ImmunoScore, despite having developed the tool three years prior. The company engaged with the FDA for approximately 18 months to ensure the tool’s safety and effectiveness. With FDA approval now secured, Prenosis plans to conduct further studies to validate the tool’s accuracy and its impact on clinical decisions, aiming to introduce it to hospitals in the U.S. and eventually worldwide.