03 August 2023 | Thursday | News
Image Source : Public Domain
Navi is currently developing the Neonav® ECG Tip Location System, which is a novel medical device designated as a Breakthrough innovation by the US Food and Drug Administration (FDA).
Navi Medical Technologies CEO Alex Newton said the Neonav is set to raise the standard of care by enabling doctors and nurses to administer therapies more safely to critically ill newborns and pediatric patients.
"At present, central catheters are inserted into the veins of critically ill newborns and young children in a blind procedure. Doctors are only able to confirm the location of the catheter with an x-ray after the procedure has already taken place. Unfortunately, this approach leads to a large number of instances where the catheters are misplaced, exposing patients to potentially life-threatening complications if left undetected."
The Neonav system, which is currently in advanced stages of development, represents a transformative solution by seamlessly connecting to a standard catheter and capturing electrical signals from the patient's heartbeat. Using a proprietary algorithm, the Neonav system provides real-time catheter location of the catheter tip. Real-time tip location allows clinicians to position the catheter quickly and safely during procedures, as well as enable ongoing surveillance of the catheter position to ensure safe continued use.
Alex Newton said funding will be channeled towards the next critical phase of work. "Primarily we're focused on completing product development activities and a major clinical trial to obtain FDA approval, which will allow us to set up our manufacturing and logistics capabilities in preparation for our entry into the U.S market."
Associate Professor Christiane Theda, Chief Medical Officer at Navi Medical Technologies, expressed her gratitude for the recent investment and emphasized the significance of this milestone, "For more than 30 years I've been dreaming of a device to assist with placement of catheters to help my patients. With the support of Breakthrough Victoria and our other partners, we're now one big step closer to bringing the Neonav ECG Tip Location System to the bedside."