GE HealthCare has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its Novii+ wireless patch, a wireless maternal and foetal monitoring solution.
Novii+ is a patch-based antepartum and intrapartum monitor that uses non-invasive methods to measure foetal heart rate, maternal heart rate, and uterine activity. The solution provides this information to care teams to have a real-time view of patient data.
According to the US-based medical technology company, Novii+’s wireless, belt-free design gives mothers the freedom and mobility for supporting their labouring experience.
Novii+ is an expanded indication from the Novii Maternal and Fetal Monitoring Solution. It uses an improved algorithm to increase accuracy and dependability.
The device can be used for antepartum as well as intrapartum pregnant patients 34 weeks and more. This extends the indication beyond the previously established 37 weeks and greater of pregnancy.
The expanded indication is based on findings submitted to the FDA to establish the accuracy and dependability of Novii+ in comparison to doppler foetal heart rate, tocodynamometer uterine activity, and pulse oximetry maternal heart rate devices for preterm patients.
GE HealthCare maternal infant care senior clinical development specialist Lisa Allen said: “Novii+ allows moms to move around and stay active during labour while providing reliable monitoring for their care teams.
“This freedom of movement can help moms have a more comfortable labour experience.”
Novii+ is said to provide care teams with a personalised view of the mother and foetus’s statuses and notifies them of changes in heart rate and contraction pattern to enable proactive intervention during labour.
Additionally, the device enables data to flow easily to current surveillance and archival systems by linking to other hospital monitors, the medical technology firm added.
The wireless maternal and foetal monitoring solution is expected to be available for US customers later this year.
