A tool from tech company Bayesian Health has become the first continuous AI sepsis monitor to gain FDA approval.
The solution monitors hospital patients to detect deterioration and flag sepsis early on. The application was developed at Baltimore-based Johns Hopkins University and commercialized by Bayesian Health.
“Presuspicion screening is what creates lead time, and lead time is what changes outcomes in sepsis. Once a clinician already suspects sepsis, the clock has been running — often for hours or even days,” said Bayesian Health founder and CEO Suchi Saria, PhD, a professor and director of the AI & Healthcare Lab at Johns Hopkins, in a May 12 news release. “No other cleared test or device monitors for sepsis prior to clinician suspicion.”
The tool has already been deployed by health systems including Cleveland Clinic, University of Rochester (N.Y.) Medicine and Fountain Valley, Calif.-based MemorialCare after receiving FDA Breakthrough Device Designation status in 2023. Epic has a popular AI sepsis detection tool, but it has not received FDA clearance as it is treated as a clinical decision support tool and not a medical device.
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