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neoNAV

Project Lead: NAVi Medical Technologies
Year: 

2017

Anticipated Classification:

Class II

Anticipated Regulatory Path:

510(k)

Initial Development Stage:

Pre-clinical

Current Development Stage:

Pre-clinical

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.

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The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) serves as a critical device development resource by providing expert advice, support services, and fund management of pediatric device innovation.

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