Navi Medical Technologies' Neonav® ECG Tip Location System Receives FDA 510(k) Clearance

Revolutionising Vascular Access Care for Critically Ill Newborns and Children

Key Points:

●FDA 510(k) Clearance Neonav® ECG Tip Location System is now FDA-cleared, enabling its use in U.S. hospitals to enhance pediatric vascular access care.

●First-of-its-kind Innovation: Neonav® is the only system designed specifically for neonatal and pediatric patients, using real-time ECG signal analysis to ensure accurate placement of Central Venous Access Devices (CVADs), significantly reducing risks like misplacement and migration.

●U.S. Market Expansion: With clearance secured, and offices in Australia and the United States, Navi Medical Technologies plans to raise capital and engage hospital networks to bring Neonav® to U.S. healthcare providers.

●Australian Innovation on the Global Stage: Based in Melbourne, Navi is demonstrating how Australian medtech can revolutionize global pediatric care.

MELBOURNE, Australia, Feb. 17, 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.

World-RevolutionFirst Technology Tailored for Pediatric Patients

The Neonav® system has the broadest 'Indication For Use' of any tip location system on the market, covering preterm newborns through to adults. Importantly, the system can be used to place tiny 1Fr catheters used in very small newborns, and is cleared for placement of catheters both above and below the heart. The system has also been developed to enable ongoing surveillance of catheters after the initial placement, an important first which can help to prevent potentially serious healthcare complications resulting from undiagnosed movement of the tip of the catheter. These novel features address critical challenges faced by healthcare professionals in neonatal and pediatric care.

Dr Janene Fuerch is a Neonatologist at Stanford Children's Health, and is excited about the prospect of the Neonav being available to assist with the treatment of  children in the United States, "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 & U.S. Expansion

With FDA clearance secured, and offices in Australian and the United States, Navi Medical Technologies will seek to raise capital later this year to support its entry into the U.S. market, "We recognize the tremendous opportunity to bring our ground-breaking technology to the U.S., and we will continue to engage hospital networks and potential partners that can help ensure that our innovations reach the patients who need them most" said Alex Newton, CEO of Navi.

"With FDA clearance in hand, we're 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. By working together, we can ensure that every critically ill child has access to safer, faster, and more effective care."

Backed by Leading Healthcare Innovators & Partners

Navi Medical Technologies acknowledges the invaluable support of its investors and partners, including Breakthrough Victoria, The Royal Women's Hospital, the Australian Federal and Victorian Governments, MTPConnect, and the US FDA Pediatric Device Consortia program. Their backing has been instrumental in achieving this milestone and advancing Navi's mission to improve pediatric healthcare worldwide.

"We wouldn't be here without the backing of our investors and partners," said Alex. "Their support and belief in our vision has enabled us to reach this point and set the stage for global expansion. We're deeply grateful for their ongoing commitment to innovation and healthcare improvement."

An Australian Success Story

The FDA clearance highlights Australia's thriving medtech sector. Minister for Economic Growth and Jobs Danny Pearson celebrated the achievement:

"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 – this is a booming industry that is backing economic growth and quality advanced manufacturing jobs across our state."

Breakthrough Victoria, an investor in Navi, also praised the company's progress. CEO Rod Bristow commented: "As an investor, we are excited about Navi's trajectory and its potential to become a leader in the paediatric medical device market. With strong fundamentals, regulatory validation, and a clear pathway to commercialisation, Navi represents a compelling investment opportunity with both financial and wider societal impact."

About Navi Medical Technologies

Navi Medical Technologies is a Melbourne-based medtech company dedicated to advancing pediatric healthcare. By collaborating with leading clinicians, Navi develops breakthrough technologies that improve outcomes for the most vulnerable patients.