Topline
Prenosis, the company behind the software, announced on Wednesday that the U.S. Food and Drug Administration has granted approval for an AI tool capable of diagnosing sepsis. This approval marks the most recent in a series of agency approvals for AI diagnostic tools.
Key Facts
The Sepsis ImmunoScore, utilizing 22 diagnostic and predictive parameters, assesses the risk of a patient developing sepsis within 24 hours. This unique combination of criteria has not been previously available in any legally marketed device for this condition, as stated in a press release.
Integrated into hospitals’ electronic medical records, the tool was developed using Prenosis’ Immunix platform, a dataset comprising over 100,000 blood samples from more than 25,000 patients.
Approved through the FDA’s De Novo pathway, the Sepsis ImmunoScore represents a novel medical device approval process.
Gary Poole, a spokesperson for Prenosis, informed Forbes that the company intends to distribute the Sepsis ImmunoScore to hospitals nationwide. Additionally, they are set to announce a distribution partnership with a major diagnostic company next week.
Big Number
At least 350,000 adults who develop sepsis either succumb to the condition or are discharged to hospice annually, according to the U.S. Centers for Disease Control and Prevention.
Key Background
Sepsis, a life-threatening condition characterized by an exaggerated response to an existing infection, impacts a minimum of 1.7 million patients each year, as per the CDC. Early indicators include fever, elevated heart rate, breathing difficulties, and confusion. Given its rapid onset and tendency to mimic common infections, sepsis can be challenging to diagnose, notes Yale Medicine. Certain groups face a higher sepsis risk, such as individuals over 65 and those who have previously battled the condition. While Prenosis’ tool secured the FDA’s initial marketing authorization, other systems like Epic Health have introduced similar tools. Despite being revamped in 2022, the efficacy of Epic’s Sepsis Model has faced scrutiny in various studies since its launch in 2021.
Tangent
Recently, the FDA cleared an algorithm developed by Mayo Clinic and startup Eko Health to assist physicians in predicting heart failure. This algorithm aids Eko Health’s digital stethoscopes in detecting low ejection fraction, a condition where the heart’s left ventricle fails to pump sufficient blood during contractions.
