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Lully Sleep Guardian

Project Lead: Lully
Year: 

2016

Anticipated Classification:

Class I

Anticipated Regulatory Path:

510(k)

Initial Development Stage:

Prototyping

Current Development Stage:

Manufacturing

Lully is addressing an unmet need to treat Primary Monosymptomatic Nocturnal Enuresis (PMNE). Lully consists of a moisture sensor and a smart pod that is placed under the mattress, which communicate to a smartphone app. When customized to the child's sleep and bedwetting pattern, the device facilitates partial awakening 15-30 minutes prior to probable bedwetting episode. NCC-PDI has provided $50,000 in direct funding as well as product sales and marketing strategy support.

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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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