The FDA approves Navi Medical Technologies' Neonav system, providing real-time ECG guidance for safer central venous access in newborns and children.
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| Navi Medical Technologies announces FDA 510(k) clearance for its Neonav ECG Tip Location System, revolutionizing vascular access care for critically ill children. Image: Freepik |
Melbourne, Australia — February 17, 2025:
Navi Medical Technologies, a company focused on pediatric healthcare innovation, has announced that its Neonav ECG Tip Location System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance marks a significant advancement in vascular access care for critically ill newborns and children, both in the U.S. and internationally.
The Neonav system, which uses real-time ECG signal analysis, is the first device of its kind specifically designed for neonatal and pediatric care. It assists healthcare professionals in the accurate placement of Central Venous Access Devices (CVADs), helping reduce the risks of misplacement and migration—issues that cost U.S. hospitals up to $1 billion annually. By minimizing the need for chest X-rays, the Neonav system can reduce care delays and lower the potential for complications in vulnerable pediatric patients.
The system boasts the broadest 'Indication for Use' of any tip location system on the market, supporting preterm newborns to adults. It is also capable of placing tiny 1Fr catheters used in very small newborns, as well as catheters above and below the heart. Additionally, the Neonav enables ongoing surveillance of catheter placement, addressing a critical gap in current neonatal and pediatric care.
Dr. Janene Fuerch, a Neonatologist at Stanford Children's Health, expressed excitement about the system’s potential to assist in the treatment of children in the U.S., emphasizing the system's ability to improve the safety and precision of central line procedures.
With FDA clearance now secured, Navi Medical Technologies plans to seek