Navi Medical Secures FDA Clearance for Neonav® Pediatric Vascular Access System

Navi Medical Technologies, a pioneering medtech company dedicated to advancing pediatric healthcare, today announced that its Neonav® ECG Tip Location System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This milestone enables the system’s use in U.S. hospitals, marking a significant step forward in neonatal and pediatric vascular access care.

The Neonav® ECG Tip Location System is the first-of-its-kind medical device designed specifically for neonates and children, utilizing real-time ECG signal analysis to ensure precise placement of Central Venous Access Devices (CVADs). By addressing the critical risks of misplacement and migration, the technology reduces reliance on confirmatory chest X-rays, streamlining clinical workflows, improving patient safety, and potentially saving U.S. hospitals up to $1 billion annually in avoidable complications.

Transforming Pediatric Vascular Access with Innovative Technology

Unlike existing tip location systems, Neonav® is uniquely tailored for pediatric use, offering the broadest "Indication for Use" in the market, covering preterm newborns through to adults. The system is cleared for:

• Placement of tiny 1Fr catheters for very small newborns.
• Catheter placement above and below the heart for enhanced procedural flexibility.
• Ongoing catheter surveillance post-placement, reducing the risk of undetected catheter movement and associated complications.

Dr. Janene Fuerch, Neonatologist at Stanford Children’s Health, emphasized the game-changing potential of Neonav®:
"Central lines are lifesaving but can be challenging to position. We need a guidance system to tell us when we are in the correct location. The Neonav system fulfills that need and gives a characteristically blind procedure a way to move forward, telling you exactly where you are and how to move into the correct position."

Strategic Growth and Expansion into the U.S.

With FDA clearance secured, Navi Medical Technologies is gearing up for U.S. market entry, strengthening its footprint beyond Australia, where the company is headquartered. The next phase involves:

• Raising capital to support commercialization and market penetration.
• Engaging U.S. hospital networks and healthcare providers to integrate Neonav® into pediatric care workflows.
• Building partnerships to scale operations and drive widespread adoption.

"We recognize the tremendous opportunity to bring our groundbreaking technology to the U.S. and will continue to engage hospital networks and potential partners to ensure that our innovations reach the patients who need them most," said Alex Newton, CEO of Navi Medical Technologies.
"With FDA clearance in hand, we are uniquely positioned to drive significant impact in the largest healthcare market in the world. Our investors have the chance to be part of a mission that’s not only financially rewarding but also deeply meaningful. Together, we can ensure that every critically ill child has access to safer, faster, and more effective care."

Global Recognition and Industry Backing

The achievement of FDA clearance further cements Australia’s position as a hub for medtech innovation, with Navi Medical Technologies standing at the forefront of pediatric healthcare advancements.

The company’s success is backed by key investors and partners, including:

• Breakthrough Victoria
• The Royal Women’s Hospital
• The Australian Federal and Victorian Governments
• MTPConnect
• The U.S. FDA Pediatric Device Consortia program

"We wouldn’t be here without the backing of our investors and partners," added Newton. "Their support has enabled us to reach this milestone and set the stage for global expansion. We are deeply grateful for their ongoing commitment to innovation and healthcare improvement."

An Australian Success Story on the Global Stage

Minister for Economic Growth and Jobs, Danny Pearson, commended Navi’s achievement, emphasizing its contribution to Victoria’s thriving medical research sector:
"This local Victorian company will be taking its home-grown technology to the United States—helping make hospital care safer for critically ill newborn babies on the other side of the world. Victoria is the medical research capital of Australia, and this is a booming industry that is backing economic growth and creating high-quality advanced manufacturing jobs across our state."

Rod Bristow, CEO of Breakthrough Victoria, echoed this sentiment, reinforcing Navi’s strong investment potential:
"As an investor, we are excited about Navi’s trajectory and its potential to become a leader in the pediatric medical device market. With strong fundamentals, regulatory validation, and a clear pathway to commercialization, Navi represents a compelling investment opportunity with both financial and wider societal impact."

Shaping the Future of Pediatric Healthcare

With FDA clearance secured and a clear path to commercialization, Navi Medical Technologies is poised to transform pediatric vascular access care, ensuring that critically ill newborns and children worldwide receive the best possible treatment.