Bayesian Health secures first FDA clearance for AI-driven continuous sepsis monitor

The US Food and Drug Administration (FDA) has cleared Bayesian Health’s continuous artificial intelligence (AI)-driven sepsis monitor, making the device the first of its kind to achieve this milestone.

The solution, which represents a segment of Bayesian’s real-time clinical intelligence platform called the Targeted Real-time Early Warning System (TREWS), secured FDA clearance through the results of a prospective study published in Nature Medicine. During the trial, researchers found that TREWS was able to detect sepsis cases early at a sensitivity of 82%, while patients were 18% less likely to die in hospitals when doctors responded to alerts issued by the technology in a timely manner.

Researchers at Johns Hopkins University originally developed the AI-powered platform to help identify cases of sepsis faster than doctors can – potentially diminishing the burden of a disease that claims at least 11 million lives globally per year, while costing hospitals more than $50bn per year.

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