Current neonatal catheters have a misplacement rate of 40%, and 50% of correctly placed catheters move to sub-optimal locations within 7 days, leading to delays in drug delivery, reduced hospital efficiency, and complications that could be fatal. The neoNAV device provides accurate localization of the Umbilical Venous Catheter tip in critically-ill newborns. With the neoNAV, physicians will be able to correctly place the catheter in the first attempt to obtain better patient outcomes and clinical efficiency. NCC-PDI is providing $50,000 in direct funding, as well as advising on sources of funding, NICU clinical expertise, and engineering consultation in conjunction with ISO standards.
Year:
2017
Anticipated Classification:
Class II
Anticipated Regulatory Path:
510(k)
Initial Development Stage:
Pre-clinical
Current Development Stage:
Pre-clinical
