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RegulationJuly 17, 2026

Noninvasive sepsis SaMD developed at Johns Hopkins offers early warnings

Bayesian Health commercialized a noninvasive sepsis monitoring software as a medical device (SaMD) developed at Johns Hopkins University and received FDA clearance. The AI/ML-based system is the first continuous sepsis monitoring platform of its kind to earn clearance and reportedly detects sepsis hours earlier than conventional clinical assessment.

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