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Novii+ Wireless Maternal and Fetal Monitoring Solution Cleared by the FDA for Monitoring Approximately 95% of All Eligible Births in the United States¹
GE HealthCare receives FDA clearance for expanded indication for Novii+ maternal and fetal monitoring solution for pregnant patients ≥34 weeks. Novii+
About this update from Ge Healthcare Technologies Inc.
[{"type":"text","content":"\n\nGE HealthCare receives FDA clearance for expanded indication for Novii+ maternal and fetal monitoring solution for pregnant patients ≥34 weeks.\n\n\n\nNovii+ noninvasively measures and displays fetal heart rate, maternal heart rate and uterine activity, while providing patient comfort and mobility in the hospital.\n\n\n\n CHICAGO--(BUSINESS WIRE)--\nGE HealthCare (Nasdaq: GEHC) today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Novii™+ Wireless Patch Solution. The antepartum and intrapartum maternal and fetal monitor noninvasively measures and displays fetal heart rate, maternal heart rate and uterine activity, so care teams can have a real-time view of patient data. Through its belt-free and wireless design, Novii+ enables mobility and freedom for mothers to support the laboring experience. Additionally, studies have shown upright positions and walking may help decrease the length of labor.2\n\n\n“Novii+ allows moms to move around and stay active during labor while providing reliable monitoring for their care teams,” said Lisa Allen, BSN, RN, senior clinical development specialist, maternal infant care, GE HealthCare. “This freedom of movement can help moms have a more comfortable labor experience.”\n\n\nNovii+ is an expanded indication from the Novii Maternal and Fetal Monitoring Solution that utilizes an updated algorithm (Cross Check artifact reduction) to improve reliability and accuracy. Novii+ can be used for both antepartum and intrapartum pregnant patients 34 weeks and greater, which extends usage before the previously defined use of 37 weeks and greater of pregnancy. The expanded indication is based on data submitted to the FDA to determine Novii+ Wireless Patch Solution’s equivalence to doppler fetal heart rate, tocodynamometer uterine activity and pulse oximetry maternal heart rate devices for preterm patients (≥34 weeks) in terms of accuracy and reliability. In the United States, Novii+ is a first-of-its-kind patch-based antepartum and intrapartum monitoring solution for preterm patients (≥34 weeks).\n\n\nMonitoring is crucial to check on health status for both pregnant patients and their fetuses particularly for preterm and high-risk pregnancies.3 Novii+ provides a personalized view of the mother and fetus’ statuses, and alerts care teams for changes t...