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Accuracy and reliability of fetal heart rate monitoring using maternal abdominal surface electrodes

This publication presents the first 3-way data of its kind comparing 3 fetal heart rate devices on labouring pregnant mothers, namely: fetal scalp ECG, Doppler ultrasound and abdominal fetal ECG – this latter device being the main IP transferred to Monica Healthcare Ltd. This collaboration, with international collaborators in the USA (waynercohen@me.com), was designed to satisfy USA FDA equivalence of abdominal fetal ECG with the classical ultrasound instrument when both are compared to the gold standard fetal scalp ECG. We successfully demonstrated that our device had improved reliability and accuracy over the ultrasound device thereby resulting in FDA approval.