Navi plans to conduct a further capital raise later this year to support its device’s access onto the US market. Image credit: Navi.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Neonav electrocardiogram (ECG) tip location system, a central venous access device (CVAD) placement platform developed by Australian company Navi Medical Technologies.

The company’s solution uses real-time ECG signal analysis to reduce the misplacement or migration of CVADs, also known as central venous catheters (CVCs), to reduce the need for confirmatory chest X-rays and other processes that can cause delays in care.

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According to Navi, Neonav has the broadest indication for use of any tip location system currently available worldwide and is the only CVAD system specifically designed for neonatal and paediatric patient care. The system is available for use in the placement of catheters in neonates with an outer diameter as small as 1 French (1Fr; 1⁄3mm).

The system also features an ongoing surveillance component to enable any complications associated with catheter tip movement to be addressed after the initial catheter placement.

Navi CEO Alex Newton commented: “We recognise the tremendous opportunity to bring our groundbreaking 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.”

The company’s current partners include the Royal Women’s Hospital, the Australian and Victorian Governments, and the FDA’s Pediatric Device Consortia programme.

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Navi has completed several funding raises, bringing its funding to date to almost $4m. With FDA clearance secured, the company plans to pursue a further capital raise later this year to support Neonav’s entry into the US market.

According to GlobalData analysis, the global CVC market is growing at a CAGR of 2.30% and is forecast to reach a valuation of around $4bn by 2033.

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