GE HealthCare has received expanded FDA 510(k) clearance for Novii+ Wireless Patch Solution for pregnant patients ≥34 weeks, according to the company. 

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.[ii]

“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.”

Novii+ 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).

Monitoring is crucial to check on health status for both pregnant patients and their fetuses particularly for preterm and high-risk pregnancies.[iii] Novii+ provides a personalized view of the mother and fetus’ statuses, and alerts care teams for changes to heart rate and contraction pattern during labor, so they can proactively intervene.

“One in ten newborns in the United States is born prematurely, a rate that has not changed significantly in over 60 years.[iv] At the same time, maternal morbidity and mortality have increased, especially for women of color,”[v] said Kurt R. Wharton, MD, FACOG, a professor and obstetrician-gynecologist.[1] ”New technologies and approaches are crucially needed to improve maternal and newborn outcomes. With the expanded indication for Novii+, care teams can now use the fetal and maternal monitoring solution for a larger number of patients faced with high-risk pregnancies,“ adds Wharton.

Intrapartum monitoring provides care teams with the data needed to care for their patients confidently and efficiently.[iii] Nearly all respondents (97%) of GE HealthCare’s The State of Flexible Healthcare Delivery [pdf] survey reported visual dashboards for monitoring patient status is moderately or critically important. By connecting to other monitors in the hospital, Novii+ allows data to flow seamlessly to existing surveillance and archival systems. The Novii+ Wireless Patch Solution will be available to customers in the United States later this year.

[1] Dr. Kurt R. Wharton is a paid consultant for GE HealthCare. The statements by Dr. Wharton described here are based on his own opinions and on results that were achieved in his unique setting. Since there is no “typical” hospital and many variables exist, i.e. hospital size, case mix, etc., there can be no guarantee that other customers will achieve the same results.

[i]  Natality, 2016-2022 expanded Request. Centers for Disease Control and Prevention. Group By: Plurality; OE Gestational Age Weekly. Accessed January 31, 2024.https://wonder.cdc.gov/natality-expanded-current.html

[ii] Lawrence A, Lewis L, Hofmeyr GJ, Dowswell T, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2009 Apr 15 ; (2) : CD003934

[iii] Ayres-de-Campos, D., Spong, C.Y., Chandraharan, E. and (2015), FIGO consensus guidelines on intrapartum fetal monitoring: Cardiotocography. International Journal of Gynecology & Obstetrics, 131: 13-24. https://doi.org/10.1016/j.ijgo.2015.06.020

[iv] Preterm birth. Centers for Disease Control and Prevention. October 24, 2023. Accessed December 29, 2023. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm

[v] Hoyert D. Maternal Mortality Rates in the United States, 2021. www.cdc.gov. Published March 16, 2023. https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-mortality-rates-2021.htm