FDA clears 1st AI sepsis diagnostic tool

The FDA has authorized the nation's first AI-powered sepsis detection tool, artificial intelligence company Prenosis said April 3. 

Clinicians have long been searching for — and testing — detection tools for sepsis, a life-threatening condition that at least 1.7 million adults in the U.S. develop each year. One in three patients who die in hospitals had sepsis during their stay, according to the CDC

The authorized device is Sepsis Immunoscore, a machine learning software that integrates with hospital EHRs, according to a Prenosis news release. It uses 22 parameters to evaluate a patient's biological status, calculate a sepsis risk score and four discrete risk categories, and display the results. The tool is not an alert system.  

Many other companies have launched similar tools, including Johns Hopkins University and Epic, but success has been spotty, CNBC reported. Prenosis' software was authorized through the FDA's De Novo pathway, meaning the agency has not authorized anything like it before. Medical devicemakers with similar solutions are recommended to seek authorization. 

Sepsis Immunoscore was built with the company's biobank and dataset, which includes more than 100,000 blood samples from more than 25,000 patients. The company said its biobank and dataset is "the largest in the world for acute care patients suspected of having serious infections."

"A solution such as the Sepsis ImmunoScore has significant potential to save lives, reduce hospital length of stay and improve compliance with payer protocols," Prenosis said.

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