Key Highlights
- FDA 510(k) clearance for Novii+ enhances maternal and fetal monitoring with a wireless, belt-free design.
- Novii+ supports mobility during labor, potentially reducing labor duration with its innovative design.
- Expanded indication for use from 34 weeks of pregnancy, improving monitoring for preterm and high-risk pregnancies.
Source: Business Wire
Notable Quotes
- “Novii+ allows moms to move around and stay active during labor while providing reliable monitoring for their care teams,” – Lisa Allen, BSN, RN, Senior Clinical Development Specialist, – Maternal Infant Care, GE HealthCare
- “One in ten newborns in the United States is born prematurely… New technologies and approaches are crucially needed to improve maternal and newborn outcomes.” – Kurt R. Wharton, MD, FACOG, Professor and Obstetrician-Gynecologist
SoH's Take
The FDA’s clearance of GE HealthCare’s Novii+ Wireless Patch Solution marks a significant advancement in maternal and fetal monitoring technology. By facilitating mobility during labor, Novii+ not only enhances the laboring experience for mothers but also has the potential to impact labor duration positively. Its expanded indication for use from 34 weeks of pregnancy underscores its utility in managing preterm and high-risk pregnancies, addressing a critical need in obstetric care. This innovation aligns with the growing demand for healthcare solutions that are both effective and empathetic, promising a new era in maternal and fetal health.
