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FDA grants de novo nod to AI tool for detecting sepsis

The CEO of Prenosis told MedTech Dive the company sees third-party validation as important, with the FDA having clarified that certain decision support tools should be regulated as medical devices.

The Food and Drug Administration granted de novo clearance to an AI tool to help clinicians predict and diagnose sepsis, the first time the agency has authorized such a tool.
The Sepsis Immunoscore software, developed by Chicago-based Prenosis, provides a risk score for clinicians on a patient having or developing sepsis within 24 hours. The score is based on 22 parameters, including respiratory rate, blood pressure and white blood cell count.
Hospitals already use early sepsis detection tools, despite lacking FDA review. The agency clarified in a final guidance in 2022 that clinical decision support software that provides a risk score or probability of a condition should be regulated as a medical device.

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