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.
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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.
It acts by continuously tracking a patient’s full record to determine their baseline and monitor meaningful changes, employing clinical reasoning to pinpoint patients who need medical attention.
Clearance of this portion of the TREWS platform, which had already won breakthrough device designation from the FDA, could be an important addition to hospital workflows. Sepsis remains the leading cause of death in American hospitals.
According to Bayesian, the FDA’s authorisation could also put the company on track to secure reimbursement for the system through US through Medicare and Medicaid’s New Technology Add-on Payment (NTAP) programme, which is slated to begin in October 2026. Currently, Bayesian is awaiting a final decision from the public payers, which the company expects in early August 2026.
Medtech industry targets early sepsis detection
While pharma and biotech companies work on new treatments for sepsis, the medtech industry is also exploring how it can help curb this disease through early detection.
Alongside Bayesian, fellow sepsis specialist Mednition previously secured a FDA breakthrough device designation for its AI-driven sepsis model, KATE AI, which demonstrated sensitivity and specificity of 95% and 96%, respectively in a retrospective study.
Isansys Lifecare secured FDA clearance for its Patient Status Engine (PSE) wireless wearable for sepsis detection almost a decade ago, which can continuously collect and feedback important changes in a patient’s vital signs to doctors. This allows them to detect early-onset sepsis quicker and more efficiently.
