Australian medical device company Navi Medical Technologies announced that its Neonav ECG Tip Location System has received US Food and Drug Administration (FDA) 510(k) clearance.
The Neonav ECG Tip Location System is designed to advance vascular access care for critically ill newborns and children.
The device is said to be the first of its kind to be designed specifically for neonatal and paediatric patients.
The FDA granted breakthrough device designation for the Neonav system in 2022.
The system uses real-time electrocardiogram (ECG) analysis to ensure precise placement of Central Venous Access Devices (CVADs). This reduces the risk of misplacement and migration, saving hospitals up to $1bn annually, the Melbourne-based medtech company said.
Neonav is also intended to minimise the need for chest X-rays, speeding up care and reducing complications for vulnerable patients.
According to Navi Medical, the system offers the broadest ‘Indication for Use’ of any tip location system, spanning from preterm newborns to adults.
It can place tiny 1Fr catheters in very small newborns and is cleared for both above and below-heart catheter placements.
The system also enables continuous catheter surveillance, preventing complications from undiagnosed catheter movement. These features address critical challenges in neonatal and paediatric healthcare, helping to improve patient outcomes.
Navi Medical Technologies CEO Alex Newton said: “We recognise the tremendous opportunity to bring our ground-breaking technology to the US, 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.
“With FDA clearance in hand, we’re uniquely positioned to drive significant impact in the largest healthcare market in the world.”
With FDA clearance in hand and offices in Australia and the US, Navi Medical Technologies plans to raise capital later this year to support its US market entry.
Navi Medical Technologies is backed by 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 programme.
Breakthrough Victoria CEO Rod Bristow said: “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.”
