THE NEOLIFE VENTILATOR IS A LOW-COST, PORTABLE DEVICE THAT PROVIDES COMPLETE BREATHING SUPPORT FOR NEWBORN BABIES.
The NeoLife Ventilator provides both CPAP and ventilation to offer breathing support and treatment to newborns with medical conditions such as apnea, asphyxia, infection, immature lungs, pneumonia and trauma.
CPAP, or continuous positive airway pressure, forces air into the patient's lungs through a fitted nose mask to keep the lungs open and lessen the work of breathing. Ventilators offer complete machine breathing for the patient through a fitted mask or an endotracheal tube inserted into the throat. These technologies are standard use for infants and adults in advanced hospitals throughout the world. The NeoLife Ventilator mimics these core functions of its high-end counterparts, but at a fraction of the cost and with little room for user error.
Several features of the device make it ideal for use in developing countries. Its durability and portability allow it to be easily transferred between health clinics in rural areas. At this stage in development it does require the use of power, but can be used with or without oxygen hookups and still be beneficial to patients. To prevent user error, the NeoLife Ventilator was designed with a simple face, color-coded tubes and hookups, and clear step-by-step instructions in the language of the target country that will remain attached to the device.
The NeoLife Ventilator was developed as a collaboration between world-class neonatologists and the engineering department at Brigham Young University. We have chosen to have it manufactured at ATL Technologies, a local medical-grade, FDA-approved equipment manufacturing facility with locations in Utah and in China.
Working with the University of Utah, we have completed rigorous safety testing to comply with 510k certification and plan to submit the NeoLife Ventilator for FDA approval by the end of May 2018, with expected approval by Fall 2018.