The US Food and Drug Administration (FDA) has granted marketing authorisation for Prenosis’ AI tool Sepsis ImmunoScore, to diagnose sepsis.
This authorisation, achieved through the De Novo pathway, represents the first-ever FDA approval of an AI/machine learning (ML) software as a medical device (SaMD) specifically for sepsis diagnosis and prediction.
Sepsis, a condition triggered by an overactive response to infection, poses a substantial burden on the US healthcare system, with billions of dollars in costs and millions of deaths annually.
