Sam Brusco, Associate Editor02.01.24
GE HealthCare has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Novii+ wireless maternal and fetal monitoring patch.
The company’s antepartum and intrapartum maternal and fetal monitor noninvasively tracks fetal heart rate, maternal heart rate, and uterine activity in real-time. Novii+ is belt-free and wireless to enable freedom and mobility and freedom for mothers to support labor—studies have shown upright positions and walking might lower the length of labor
Novii+ is an expanded indication of GE HealthCare’s solution that uses Cross Check artifact reduction to boost reliability and accuracy. Novii+ can be used in patients 34 weeks pregnant or later, three weeks earlier than the previously defined use.
The expanded indication is based on Novii+’s demonstrated equivalence to doppler fetal heart rate, tocodynamometer uterine activity and pulse oximetry maternal heart rate devices for preterm patients. GE HealthCare said it’s the first patch-based antepartum and intrapartum monitoring solution for preterm patients (≥34 weeks) in the U.S.
Novii+ offers a personalized view the mother and fetus’ statuses and sends alerts for heart rate changes and contraction patterns during labor.
“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.”
Kurt R. Wharton, MD, FACOG, a professor and obstetrician-gynecologist and consultant for the company, said one in ten U.S. newborns is born prematurely and that rate hasn’t changed in over 60 years.
“At the same time, maternal morbidity and mortality have increased, especially for women of color,” Dr. Wharton said. “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.”
The company’s antepartum and intrapartum maternal and fetal monitor noninvasively tracks fetal heart rate, maternal heart rate, and uterine activity in real-time. Novii+ is belt-free and wireless to enable freedom and mobility and freedom for mothers to support labor—studies have shown upright positions and walking might lower the length of labor
Novii+ is an expanded indication of GE HealthCare’s solution that uses Cross Check artifact reduction to boost reliability and accuracy. Novii+ can be used in patients 34 weeks pregnant or later, three weeks earlier than the previously defined use.
The expanded indication is based on Novii+’s demonstrated equivalence to doppler fetal heart rate, tocodynamometer uterine activity and pulse oximetry maternal heart rate devices for preterm patients. GE HealthCare said it’s the first patch-based antepartum and intrapartum monitoring solution for preterm patients (≥34 weeks) in the U.S.
Novii+ offers a personalized view the mother and fetus’ statuses and sends alerts for heart rate changes and contraction patterns during labor.
“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.”
Kurt R. Wharton, MD, FACOG, a professor and obstetrician-gynecologist and consultant for the company, said one in ten U.S. newborns is born prematurely and that rate hasn’t changed in over 60 years.
“At the same time, maternal morbidity and mortality have increased, especially for women of color,” Dr. Wharton said. “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.”