The U.S. Food and Drug Administration approved an AI tool that can diagnose sepsis, Prenosis, the company behind the software, announced Wednesday, the latest in a series of agency approvals for AI diagnostic tools.Sepsis, a life-threatening condition that manifests as an extreme response to an existing infection, affects at least 1.7 million patients annually, according to the CDC. Early signs include fever, high heart rate, shortness of breath and confusion. The condition develops quickly and can be difficult to diagnose since it often presents as a common infection, according to Yale Medicine. Several groups are at higher risk of developing sepsis, including adults older than 65 and patients who have survived a bout with the condition, according to the CDC. While the agency granted its first marketing authorization to Prenosis’ tool, other systems, such as Epic Health, have released similar tools. The effectiveness of Epic’s Sepsis Model has been scrutinized in multiple studies since its 2021 launch, despite being reportedly revamped in 2022.
FDA Approves AI Tool That Can Detect Sepsis
Published On - April 4, 2024
