Navi Medical Technologies has introduced the Neonav® ECG Tip Location System, a groundbreaking device designed to enhance the safety and efficiency of delivering critical medications and fluids to newborns via central venous access devices (CVADs). This innovation addresses long-standing challenges in pediatric care, particularly the difficulty of placing CVADs in the small and delicate veins of infants.
Placing a CVAD involves inserting a thin, flexible tube into a large vein, allowing for direct delivery of essential treatments. The procedure traditionally requires clinicians to estimate catheter length and position without direct visual guidance, often using X-rays post-insertion to confirm placement. Such complexities can lead to complications, especially in vulnerable newborns.
Transforming Pediatric Care
The Neonav® system utilizes electrocardiographic signals to track catheter placement in real-time, significantly reducing the reliance on X-rays and enhancing patient safety. This innovation stems from a classroom project undertaken by co-founder and Chief Operating Officer, Shing Yue Sheung, during his Master of Biomedical Engineering program at the University of Melbourne.
In developing the Neonav® system, Sheung and his team sought insights from Associate Professor Christiane Theda, a seasoned neonatologist with over 30 years of experience in neonatal intensive care. Her firsthand accounts of the challenges involved in locating catheter tips during and after placement inspired the team to explore solutions tailored specifically for pediatric patients.
“We found a significant gap in purpose-built medical devices for children,” Sheung noted. Most manufacturers focus primarily on adult needs, leaving a critical void in pediatric healthcare solutions.
The team committed to refining their concept even after graduation, dedicating weekends to advance their project while balancing work and studies.
Support from CTCM Program
The journey of Neonav® gained momentum through participation in the Clinical Translation and Commercialisation MedTech (CTCM) program, an initiative under the Medical Research Future Fund. The program provided essential resources to help Navi Medical Technologies achieve two critical objectives: conducting a pilot clinical study to validate the technology and developing a comprehensive business plan for market entry.
Collaboration with the Royal Women’s Hospital was instrumental in executing a pilot study that informed product design. The team engaged in extensive research, conducting over 200 clinical interviews and accumulating 250 clinical recordings alongside 100 product demonstrations. Feedback from these activities was pivotal in refining the Neonav® system.
Additionally, guidance from Cicada Innovations helped the team progress Neonav’s Technology Readiness Level from level 5 to level 7, indicating its advancement toward commercial viability.
The Neonav® system received clearance from the United States Food and Drug Administration in January 2025, paving the way for its launch in US hospitals.
Sheung has since relocated to the United States to facilitate the rollout and expansion of Navi Medical Technologies. He expressed excitement about the future, stating, “My mission is threefold: support our initial customers in the USA, expand our US-based team, and build relationships with strategic partners and investors.”
The team at Navi Medical Technologies remains committed to impacting the lives of newborns. “If we can make a difference in those early days of life, it means everything,” Sheung emphasized. By improving clinical practices, they hope to enhance outcomes for infants, contributing to healthier futures.
