From:  Integration of biomedical imaging and sensing technologies with AI-IoT for Materiovigilance and predictive modeling of stillbirth risk in maternal-fetal health monitoring

 AI-IoT integration frameworks for stillbirth monitoring and Materiovigilance.

Framework layerAI-IoT componentsRole in stillbirth monitoringRole in Materiovigilance & risk reductionRepresentative references
Sensing layerFoetal movement, pressure, phonocardiography, ECG/PPG wearables.Continuous acquisition of foetal activity, foetal heart sounds, and maternal physiological messages.Early detection of material breakdown, over-contact pressure and skin-device contacts.[26, 27]
Data acquisition & IoT connectivityBLE, Wi-Fi, IoMT gateways, wearables connected to the cloud.Provides the transmission of maternal-foetal information in real-time to facilitate round-the-clock monitoring.The remote device performance tracking, fault detection, and adverse event reporting are supported.[22]
Edge intelligence layerML-based artefact removal algorithms, edge AI.Reduces motion artifacts and improves fetal signal reliability.Detects abnormal sensor behavior, drift, or hardware malfunction in early stages.[28]
Cloud analytics layerTime-series analysis, predictive models, and deep learning.Determines abnormal foetal movements and early foetal distress.Anticipates failure of devices, false positives, and material fatigue.[29, 30]
Clinical decision support systems (CDSS)Risk scoring, alerts, dashboards: AI.Helps clinicians make decisions that can help the foetus and intervene.Flags suspicious activity of devices and assists in reporting of regulations.[31]
User interface layerM-health applications, clinician portals, visualisations.Enhances the comprehension of foetal health indicators to users.Cuts psychological stress levels by cutting false alarms and enhancing transparency.[32]
Materiovigilance & feedback loopAdverse event detection under AI control, automated reporting.Correlates maternal births to device performance statistics.Facilitates active after-market monitoring, design efficiency, and safety assurance.[33]
Security & privacy layerAI in cybersecurity and anomaly detection, encrypted IoT protocols.Secures confidential maternal/foetal health information.Eliminates manipulation of data, unauthorized access, and safety hazards.[34]

AI: artificial intelligence; ECG: electrocardiography; IoT: Internet of Things; ML: machine learning.