Prenosis Announces FDA Approval of AI Tool for Sepsis

Health technology company Plenosis on Wednesday announced The company's artificial intelligence-powered sepsis diagnostic tool is the first to receive approval from the U.S. Food and Drug Administration.

Sepsis occurs when the body overreacts to an infection and can often lead to death. According to the report, more than 350,000 adults with sepsis die during hospitalization or are discharged to hospice care each year. Centers for Disease Control and Prevention. Sepsis is notoriously difficult to diagnose, but early detection is important because a patient's condition can deteriorate rapidly.

Prenosis' tool, Sepsis ImmunoScore, uses 22 different parameters, including body temperature, heart rate and cell count, to help clinicians assess a patient's sepsis risk, the company told CNBC. Physicians and nurses often need to monitor these parameters individually. Prenosis’ solution uses AI to assess all of these markers at once. The tool generates an overall risk score and four categories that “correlate with a patient's risk of deterioration,” according to the release.

The Sepsis Immune Score was built using Prenosis' Immunix platform, which is based on a dataset of more than 100,000 blood samples from 25,000 different patients, the release states.

This tool integrates directly into the electronic health record, where clinicians create and manage patient medical records. Incorporating the Sepsis Immune Score within existing workflows means it will be easier to use and access, Plenosis said. Clinicians can also see a display showing exactly which parameters were used to calculate the overall risk score.

Prenosis' solution has been approved through the FDA route again, which means that authorities have never approved anything like the Sepsis Immune Score before. It's a big win for the 10-year-old Chicago-based startup.

Prenosis is the first company to receive FDA approval for an AI diagnostic tool for sepsis, but several organizations have built and released similar solutions. For example, Johns Hopkins University built an AI system aimed at detecting sepsis symptoms faster.a 2022 survey A paper published in Nature Medicine found that in severe cases, the university's AI model detected sepsis on average six hours earlier than traditional methods.

Epic Systems, a major healthcare software vendor, has also developed an AI-powered sepsis prediction tool, but its model has come under considerable criticism in recent years. According to some information, Epic's sepsis model is used in hundreds of hospitals across the United States. 2021 survey Published in JAMA Internal Medicine. However, the researchers said the model was “poorly predictive of sepsis” and “widely adopted despite poor performance, raising fundamental concerns for sepsis management at the national level.” The study found that “there is.”

Epic denies the findings, and the company blog post Healthcare organizations say the technology has improved mortality rates from sepsis. Still, Epic reportedly overhauled its sepsis model the following year to improve performance. statistics news.

Plenosis told CNBC that it could have brought Sepsis ImmunoScore to market as is, but it did not intend to sell the product without FDA approval. The company said the tool has been ready for about three years, but it wants to work with regulators to recognize safety concerns and ensure the technology does no harm.

In addition, the F.D.A. Updated guidance It announced to businesses in September 2022 that it shared examples of device software features that it “intends to focus on regulatory oversight.” The agency said software that “analyzes patient-specific medical information to detect life-threatening conditions such as stroke and sepsis” falls into this category.

In other words, the agency suggests that companies developing sepsis detection tools should seek formal approval.

Plenosis said it worked for approximately 18 months to prove the safety and effectiveness of Sepsis Immunoscore to the FDA. Now that the company has received regulatory approval, it plans to conduct additional studies to demonstrate the tool's accuracy and impact on clinical decision-making. Prenosis will begin selling the tool to hospitals in the United States and eventually to hospitals around the world, the company said.