AI Diagnostic Tool for Sepsis Gets FDA Nod

The first-ever sepsis diagnostic powered by AI has been granted De Novo marketing authorization by the FDA, addressing a decades-long and expensive challenge for the U.S. healthcare system — rapid diagnosis and prediction of sepsis.

Prenosis’s Sepsis ImmunoScore is an AI/machine learning software as a medical device that is integrated directly into hospital electronic medical records, giving clinicians easy access to the patient’s risk scores and the ability to make fast treatment decisions if the patient demonstrates a high risk for sepsis.

Sepsis, which occurs when a person has an overactive response to an infection, costs the U.S. healthcare system billions of dollars and kills millions of people every year — more than all cancers combined. Early intervention is key to a complete recovery.

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