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Kidney Reflux Detection Device

Project Lead: Kite Medical
Year: 

2017

Anticipated Classification:

Class II

Anticipated Regulatory Path:

510(k)

Initial Development Stage:

Clinical

Current Development Stage:

Clinical

Kite Medical has developed a device that offers a pain-free, non-invasive means of detecting Kidney Reflux in children with Urinary Tract Infections (UTIs), thereby dramatically reducing (by approximately 92%) the need for a traumatizing, expensive Voiding Cystourethrogram (VCUG) procedure. NCC-PDI provided advisory support with respect to scientific and clinical feasibility and potential regulatory path to market.

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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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