Sibel Health has received 510(k) clearance from the Food and Drug Administration for ANNE Maternal, a wireless platform designed to continuously monitor both maternal and fetal health. The system combines wearable sensor technology with clinical decision support to enable real-time tracking of vital signs during pregnancy, labour and postpartum care.
ANNE Maternal uses soft, flexible wearable sensors placed on the skin to capture key maternal metrics such as heart rate, respiratory rate, oxygen saturation and temperature, alongside fetal heart rate and uterine activity. Unlike traditional wired monitoring systems that restrict movement, the platform allows patients to remain mobile while maintaining clinical-grade monitoring. It also includes real-time alerts, central and bedside monitoring, and an integrated early warning system that notifies clinicians when intervention may be needed.
The platform builds on Sibel Health’s existing ANNE One system and is designed for use across both high-resource and low-resource settings. It integrates with wireless point-of-care ultrasound to provide a more complete view of maternal and fetal health within a single interface. Development was supported by funding from the Bill & Melinda Gates Foundation, with additional investment aimed at incorporating AI-driven capabilities in the future.
Already deployed in countries including Pakistan, Rwanda, Nigeria and India through partnerships with academic and global health organisations, the system reflects a broader push to make continuous maternal monitoring more accessible worldwide while maintaining high clinical standards.
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