Fetal Monitoring Signal Optimization Device

Abstract

Despite being the clinical standard and a primary means of intrapartum assessment, current fetal monitoring devices have extremely high false positive rates (up to 99% for fetal distress signs like fetal acidosis). This means clinicians are often reacting to signals that don’t reflect the baby’s true condition. This not only creates confusion but also causes unnecessary interventions like C-sections and other surgical procedures. To solve this problem, LifeCycle came up with Fetosync, an AI-powered intrapartum signal processing and interpretation module. Rather than replacing existing fetal monitors, Fetosync integrates directly with them and processes maternal and fetal heart rates and maternal uterine contractions in real time. It works by collecting incoming signals, separating maternal and fetal components and applying machine learning to classify events. Fetosync’s prototype demonstrates core functionality across the hardware and software components, including successful processing of clinical datasets and transmission of signals through the filtering system. Prototype validation confirms effective waveform handling and refinement of filter parameters. User interface features were reviewed and largely validated by an OBGYN, supporting clinical relevance. Regulatory analysis established a clear Class II pathway (510k). These outcomes demonstrate progress toward a functional, clinically applicable fetal monitoring plug-in module. Unreliable fetal monitors do not affect just the baby but also cause risks and complications in the mother’s body increasing the liability for hospitals. With the implementation of Fetosync, which sits between existing monitoring hardware and clinical interpretation, LifeCycle ensures seamless integration with no additional installation costs while also promising reliable and safe clinical monitoring outcomes.

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