- GE HealthCare receives FDA clearance for expanded indication
for Novii+ maternal and fetal monitoring solution for pregnant
patients ≥34 weeks.
- Novii+ noninvasively measures and displays fetal heart rate,
maternal heart rate and uterine activity, while providing patient
comfort and mobility in the hospital.
GE 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
“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.3 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.4 At the
same time, maternal morbidity and mortality have increased,
especially for women of color,”5 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.
_____________________________
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.
Intrapartum monitoring provides care teams with the data needed
to care for their patients confidently and efficiently.3 Nearly all
respondents (97%) of GE HealthCare’s The State of Flexible
Healthcare Delivery 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.
GE HealthCare designs solutions to meet the needs of providers,
families, and patients to support care that can help send moms and
babies home healthy. For more information on our fetal and maternal
monitoring solutions, please visit:
https://www.gehealthcare.com/products/maternal-infant-care/fetal-monitors
ABOUT GE HEALTHCARE TECHNOLOGIES INC.
GE HealthCare is a leading global medical technology,
pharmaceutical diagnostics, and digital solutions innovator,
dedicated to providing integrated solutions, services, and data
analytics to make hospitals more efficient, clinicians more
effective, therapies more precise, and patients healthier and
happier. Serving patients and providers for more than 100 years, GE
HealthCare is advancing personalized, connected, and compassionate
care, while simplifying the patient’s journey across the care
pathway. Together our Imaging, Ultrasound, Patient Care Solutions,
and Pharmaceutical Diagnostics businesses help improve patient care
from prevention and screening, to diagnosis, treatment, therapy,
and monitoring. We are an $18 billion business with 50,000
employees working to create a world where healthcare has no
limits.
Follow us on Facebook, LinkedIn, Twitter, Instagram and Insights
for the latest news, or visit our website www.gehealthcare.com for
more information.
___________________________
1Natality, 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
2Lawrence 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
3Ayres-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
4Preterm birth. Centers for
Disease Control and Prevention. October 24, 2023. Accessed December
29, 2023.
https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm
5Hoyert 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
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GE HealthCare Media Contact: Jennifer Purdue M +1 267 593
9735 jennifer.purdue@gehealthcare.com
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