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. Our long-term objective is to improve pediatric health care by increasing the number of effective pediatric medical devices and contribute to the national effort to address the unmet need for pediatric medical devices.
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Projected Device Classification
Anticipated Regulatory Path
Cardiac arrhythmias can affect the quality of life and lead to morbidity and mortality in pediatric patients. Prompt diagnosis and appropriate early management can potentially prevent life threatening events, restore functional capacity, and improve quality of life for the child and family. The Carnation Ambulatory Monitor (CAM) is the first P-wave centric ECG patch monitor, […]
In pediatric cardiovascular surgery, no commercially available vascular conduit is capable of growing with the patient following implantation. This inability to grow with the patient is particularly relevant for newborns and young children because additional surgeries are required to replace the implanted conduit. In order to address this issue, PECA Labs has developed a novel […]
Our proposed project is for execution of pilot studies using the Endothelial Cell Culture Model (ECCM) developed by Dr. Palaniappan Sethu (Associate Professor of Medicine and Biomedical Engineering, University of Alabama-Birmingham (UAB)) and Dr. Guruprasad Giridharan (Professor, Associate Chair of Bio-Engineering, University of Louisville). Studies will be conducted at UAB to evaluate the acute response […]
Therapeutic options for heart failure (HF) in the pediatric population are severely limited. Pediatric patients requiring mechanical circulatory support (MCS) have very high mortality and adverse event rates. Clinicians currently depend on the Berlin Heart EXCOR pediatric device, which severely limits ambulation and precludes hospital discharge, or adult MCS devices (used off-label), which require a […]
Congenital heart disease (CHD) is the most common type of birth defect, and one of the leading causes of child mortality in the developed world. One of the most vexing problems that children with CHD face is the poor durability of replacement heart valves, with the pulmonary valve being the most commonly replaced heart valve […]
Prapela next gen baby box integrates a clinically proven, stochastic, vibrating sleeping surface into a baby box to be used in the hospital and provided at discharge for use at home. The baby box relaxes drug-exposed newborns too frantic to eat or sleep. Ideal for treating Neonatal Abstinence Syndrome , Prapela can help reduce length […]
ANEclear is an inexpensive, easy-to-use, disposable device that quickly and actively removes unwanted inhaled anesthetics following surgery. The use of this device creates a reduction in the effects of residual agents, leading to improved patient and surgeon satisfaction. NCC-PDI provided consultation services on the potential pediatric need and path to market clearance.
GSM Dynamic Brace introduces a non-operative treatment approach to treating Adolescent Idiopathic Scoliosis. GSM Dynamic Brace uses the concept of tissue remodeling, similar to that used in orthodontics to overcome the limitations of rigid bracing. NCC-PDI is providing $50,000 in direct funding, as well as design validation, clinical expertise, and commercialization support. The device will […]
The Pediatric Vision Scanner (PVS) is the solution to amblyopia and strabismus detection. The PVS device is a handheld device that scans both eyes of a child in under 3 seconds and can be operated by a non-clinician with no requisite skills. The technology capitalizes on a polarization phenomenon that is unique to the eye […]
Pediatric patients have been as poorly served by inadequate prosthetic sockets as adults. LIM Innovations adult above-knee prosthetic socket is new in terms of structure, use of thermoplastic- fiber composite materials, custom-fit, and adjustability. It delivers a highly individualized fit via a mass customization approach. It is intended to leverage lessons learned in design, engineering, […]