Navi Medical Technologies’ Neonav® ECG Tip Location System Receives FDA 510(k) Clearance
Revolutionising Vascular Access Care for Critically Ill Newborns and Children
MELBOURNE, Australia, Feb. 16, 2025 /PRNewswire/ — Navi Medical Technologies, a medical device company focused on pediatric healthcare innovation, proudly announces that its Neonav® ECG Tip Location System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
This milestone represents a significant step forward in vascular access care for critically ill newborns and children worldwide. The Neonav® is the first medical device of its kind specifically designed for neonatal and pediatric care. By using real-time ECG signal analysis, it aids accurate placement of Central Venous Access Devices (CVADs), significantly reducing the risks associated with misplacement and migration which can cost US hospitals up to USD$1 Billion per year. This breakthrough innovation minimises reliance on confirmatory chest X-rays, will help in reducing delays in care, as well as lowering unintended complications for vulnerable patients.
