FDA Authorizes AI Tool to Diagnose Sepsis, a Major Breakthrough in Healthcare

Obaid Ahsan

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Sepsis, a Deadly Condition with Urgent Need for Improved Diagnosis

Sepsis is a life-threatening condition that occurs when the body’s response to an infection spirals out of control. It can lead to tissue damage, organ failure, and even death if not treated promptly. According to the Centers for Disease Control and Prevention (CDC), at least 350,000 adults in the United States die from sepsis or are discharged to hospice each year. Early detection of sepsis is crucial, as patients can deteriorate rapidly. However, diagnosing sepsis is notoriously challenging, as it often presents with symptoms similar to common infections.

Prenosis Receives FDA Approval for Groundbreaking AI-Powered Sepsis Diagnostic Tool

In a significant breakthrough, the U.S. Food and Drug Administration (FDA) has authorized the Sepsis ImmunoScore, an artificial intelligence-powered diagnostic tool developed by the health technology company Prenosis. This marks the first time the FDA has approved an AI tool specifically designed to diagnose sepsis.

The Sepsis ImmunoScore utilizes 22 different parameters, including temperature, heart rate, and cell counts, to assess a patient’s risk of developing sepsis within 24 hours. Traditionally, clinicians have had to monitor each of these parameters individually, but Prenosis’ AI-powered solution evaluates all of these markers simultaneously to generate an overall risk score and four risk categories that correlate to a patient’s likelihood of deterioration.

“Sepsis is notoriously challenging to diagnose, but early detection is key since patients can deteriorate quickly,” said Ashley Capoot, the author of the CNBC article. “Prenosis’ tool, called Sepsis ImmunoScore, uses 22 different parameters like temperature, heart rate and cell counts to help clinicians assess a patient’s risk of sepsis.”

The Sepsis ImmunoScore was built using Prenosis’ Immunix platform, which is based on a dataset of more than 100,000 blood samples from 25,000 different patients. This extensive dataset allows the AI system to analyze a wide range of patient data and provide a comprehensive risk assessment.

Approval Through FDA’s De Novo Pathway Signifies Innovative Approach

Prenosis’ Sepsis ImmunoScore was approved through the FDA’s De Novo pathway, which is used for novel medical devices that have not been previously authorized. This means that the agency has not approved anything like the Sepsis ImmunoScore before, highlighting the innovative nature of Prenosis’ solution.

“Prenosis’ solution was approved through the FDA’s De Novo pathway, which means the agency has not authorized anything like Sepsis ImmunoScore before. It’s a big win for the 10-year-old Chicago-based startup,” Capoot noted.

The FDA’s decision to approve the De Novo pathway underscores the agency’s recognition of the potential impact that AI-powered diagnostic tools can have in improving patient outcomes, particularly for complex and time-sensitive conditions like sepsis.

Integrating Sepsis ImmunoScore into Existing Healthcare Workflows

One of the key features of the Sepsis ImmunoScore is its seamless integration into existing electronic health record (EHR) systems. By embedding the tool directly into clinicians’ workflows, Prenosis aims to ensure that it is easily accessible and user-friendly.

“Embedding Sepsis ImmunoScore within existing workflows means it will be easy to use and access, Prenosis said. Clinicians will also see a display that shows exactly which parameters were used to calculate the overall risk score,” Capoot explained.

This integration is crucial, as it allows healthcare providers to quickly and efficiently incorporate the Sepsis ImmunoScore into their routine patient assessments, potentially leading to earlier detection and intervention for sepsis.

Addressing Safety Concerns and Regulatory Oversight

Prenosis took a thoughtful and deliberate approach in seeking FDA approval for the Sepsis ImmunoScore, despite the fact that the company could have gone directly to the market with the tool around three years ago.

“Prenosis told CNBC that while it could have gone straight to market with Sepsis ImmunoScore, it did not want to try and sell the product without FDA approval. The company said the tool was ready around three years ago, but it wanted to work with regulators to be conscious of safety concerns and ensure that the technology does not cause harm,” Capoot reported.

The FDA’s updated guidance in September 2022, which specifically highlighted the need for regulatory oversight of software that “analyzes patient-specific medical information to detect a life-threatening condition, such as stroke or sepsis,” further underscored the importance of Prenosis’ decision to seek formal approval.

By working closely with the FDA for approximately 18 months to demonstrate the safety and efficacy of the Sepsis ImmunoScore, Prenosis has ensured that its tool meets the agency’s rigorous standards, providing healthcare providers and patients with the confidence that the technology is both reliable and safe.

Competitive Landscape and Ongoing Challenges

While Prenosis is the first company to receive FDA approval for an AI-powered sepsis diagnostic tool, it is not the only organization working on similar solutions.

Johns Hopkins University has developed an AI system that aims to detect sepsis symptoms more quickly, with a study published in Nature Medicine finding that the university’s AI model detected sepsis an average of six hours earlier than traditional methods in severe cases.

Epic Systems, a leading healthcare software vendor, has also created an AI-powered sepsis prediction tool, though it has faced substantial criticism in recent years. A 2021 study published in JAMA Internal Medicine found that Epic’s sepsis model “poorly predicts sepsis,” and that “its widespread adoption despite poor performance raises fundamental concerns about sepsis management on a national level.” In response, Epic reportedly overhauled its sepsis model in 2022 in an attempt to improve its performance.

Despite these ongoing challenges, the approval of Prenosis’ Sepsis ImmunoScore represents a significant milestone in the development of AI-powered diagnostic tools for life-threatening conditions. As the technology continues to evolve, it will be essential for healthcare providers, researchers, and regulatory agencies to work together to ensure the safety, accuracy, and clinical utility of these innovative solutions.


The FDA’s authorization of Prenosis’ Sepsis ImmunoScore marks a major breakthrough in the fight against sepsis, a condition that has long been a significant challenge for healthcare providers. By leveraging the power of artificial intelligence to analyze a comprehensive set of patient data, the Sepsis ImmunoScore has the potential to revolutionize the way clinicians diagnose and manage this deadly condition.

As the healthcare industry continues to embrace the transformative potential of AI, the approval of the Sepsis ImmunoScore serves as a hopeful example of how this technology can be successfully integrated into clinical practice to improve patient outcomes. With continued collaboration between innovators, healthcare providers, and regulatory agencies, the future of AI-powered diagnostics in medicine looks increasingly promising.

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