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.
Year:
2017
Anticipated Classification:
Class II
Anticipated Regulatory Path:
510(k)
Initial Development Stage:
Clinical
Current Development Stage:
Clinical
