Anumana vs Sepsis ImmunoScore

Each tool has an FDA decision, so regulation does not separate them. A cardiology chief would be the one to sign for Anumana, whose four ECG-AI 510(k)s date from 2023 to 2026. A 2026 JACC Advances paper validated an AI-ECG low ejection fraction algorithm at several sites, and its link to the cleared algorithm is not verified.

Prenosis holds a De Novo, DEN230036, dated April 2, 2024, for Sepsis ImmunoScore. The score draws on up to 22 EHR parameters, including procalcitonin, CRP and lactate, and sorts adults admitted to the ED or hospital with suspected sepsis into four bands for deterioration risk within 24 hours. The vendor states it has not been validated in the ICU or on labor and delivery units, so a sepsis program focused on ICU patients cannot lean on the De Novo for that setting. A 2024 NEJM AI paper reports its development and validation, and the vendor page lists Prenosis authors on it. The homepage names Carle Health as a deployment.