FDA grants de novo nod to AI tool for detecting sepsis

MedTech Dive April 4, 2024
Elise Reuter

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.

Dive Brief:

• 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...

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