A sign outside the U.S. Food and Drug Administration headquarters in White Oak, Maryland, on August 29, 2020.
Andrew Kelly | Reuters
On Wednesday, health tech company Prenosis declare Its AI-driven sepsis diagnostic tool is the first to receive U.S. Food and Drug Administration approval.
Sepsis occurs when the body has an extreme reaction to an infection and is often fatal. According to the agency, more than 350,000 adults with sepsis die each year while hospitalized or are discharged to hospice. Centers for Disease Control and Prevention. Diagnosis of sepsis is notoriously challenging, but early detection is key because patients’ condition can deteriorate rapidly.
Prenosis told CNBC that the company’s tool, called the Sepsis Immune Score, uses 22 different parameters such as temperature, heart rate and cell count to help clinicians assess a patient’s risk of developing sepsis. Physicians and nurses often must monitor these parameters individually. Prenosis’ solution uses artificial intelligence to evaluate all of these markers at once. The tool produces an overall risk score and four categories “associated with a patient’s risk of worsening,” according to a press release.
The sepsis immune score was built using Prenosis’ Immunix platform, which is based on a data set of more than 100,000 blood samples from 25,000 different patients, according to the release.
The tool integrates directly into electronic health records, where clinicians can build and manage patients’ medical records. Prenosis said embedding the sepsis immune score into existing workflows means it will be easy to use and access. Clinicians will also see a display showing exactly which parameters are used to calculate the overall risk score.
Prenosis’ solution receives FDA approval pass again, meaning the agency has not authorized something like a sepsis immune score before. It’s a huge win for the 10-year-old Chicago startup.
While Prenosis is the first company to receive FDA approval for its sepsis AI diagnostic tool, several organizations have already built and released similar solutions. For example, Johns Hopkins University built an artificial intelligence system designed to detect sepsis symptoms more quickly. A Study in 2022 Research published in Nature Medicine found that in severe cases, the university’s artificial intelligence model detected sepsis an average of six hours earlier than traditional methods.
Leading medical software provider Epic Systems has also developed an artificial intelligence-powered sepsis prediction tool, although the company’s model has been heavily criticized in recent years.Epic’s sepsis model is already in use at hundreds of U.S. hospitals, according to one hospital Study in 2021 Published in JAMA Internal Medicine. But the researchers found that the model “poorly predicted sepsis” and that “despite its poor performance, its widespread adoption raises fundamental concerns about sepsis management at the national level,” the study said.
Epic disputed the findings, releasing a Blog article That said, healthcare organizations have seen sepsis mortality rates improve as a result of their technology. Even so, Epic reportedly overhauled its sepsis model the following year in an attempt to improve its effectiveness. statistical news.
Prenosis told CNBC that while it could have brought the sepsis immune score directly to market, it didn’t want to try to sell the product without FDA approval. The company said the tool was ready about three years ago but it wanted to work with regulators to be aware of safety concerns and ensure the technology did not cause harm.
In addition, the FDA Updated guidance Information provided to the company in September 2022 and shared examples of device software functionality, which “intends to focus on its regulatory oversight.” The agency said software that “analyzes patient-specific medical information to detect life-threatening conditions such as stroke or sepsis” falls into this category.
In other words, the agency recommended that companies developing sepsis testing tools should seek official authorization.
Prenosis said it took about 18 months to prove the safety and effectiveness of the sepsis immune score to the FDA. Now that the company has received approval from the agency, it will conduct additional studies to demonstrate the tools’ 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.
About The Author
