Enhancing Care for Newborns Needing Lifesaving Medications and Fluids

Enhancing Care for Newborns Needing Lifesaving Medications and Fluids

22 Sep 2025

CVADs are thin, flexible tubes inserted into large veins to deliver essential medications and fluids directly into the bloodstream, often saving the lives of critically ill children. But inserting a CVAD in tiny, fragile veins is challenging. Clinicians must estimate the correct catheter length, place it without direct visual guidance, and then confirm its position using X-rays. Even then, the catheter can move, potentially causing complications.

To address this, Navi developed the Neonav® ECG Tip Location System, a non-invasive device that tracks CVADs in real time using electrocardiographic signals. The system reduces reliance on X-rays and improves patient safety.

From classroom project to life-changing mission

Co-founder and COO Shing Yue Sheung (Shawn) explains that the idea began as a university project during his Master of Biomedical Engineering at the University of Melbourne. Insights from neonatologist Associate Professor Christiane Theda, who has over 30 years’ experience in neonatal intensive care, highlighted the challenges of CVAD placement and the lack of purpose-built devices for paediatric patients.

The team continued developing the concept after university, working on weekends while studying and gaining early experience in prototyping and design.

Clinical translation and commercialisation support

Navi progressed the Neonav project through the Clinical Translation and Commercialisation MedTech (CTCM) program, a Medical Research Future Fund initiative delivered by MTPConnect. The program helped Navi complete a pilot clinical translation study, refine the device design, develop a business plan, and recruit key personnel.

Collaborating with the Royal Women’s Hospital and design partner Design+Industry, the team conducted over 200 clinical interviews, 250 clinical recordings, and 100 product demonstrations, incorporating feedback to optimise the device. Mentoring from Cicada Innovations also supported the team, advancing Neonav’s Technology Readiness Level from 5 to 7.

Impact and future plans

In January 2025, Neonav® received US FDA clearance and has since launched in US hospitals. Shawn has relocated to the US to support rollout, grow the team, and develop strategic partnerships and investment opportunities.

“Our mission is threefold: support Navi’s first customers in the US, expand our US-based team, and build strategic relationships,” Shawn says. “We believe helping newborns in these critical early days can have a lifelong impact, improving outcomes for babies and supporting clinicians in delivering the best care possible.”

Source: Navi Medical Technologies

 

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