The design and development of the NeoLife Ventilator began more than ten years ago. In the years since our engineers have worked tirelessly to develop a ventilator to meet all of Neonatal Rescue’s goals: a portable ventilator that was affordable and had battery-powered capabilities. In 2020 as the COVID-19 pandemic strained the medical system. Neonatal Rescue knew that we had to help and knew we could. We adapted our existing newborn ventilator to accommodate adult patients with COVID-19. We submitted the modified device for FDA approval and received FDA Emergency Use Authorization in June 2020. While we are proud of our adult adaptation, Neonatal care has always been at the forefront of our minds.
The design and development of the NeoLife Ventilator began more than ten years ago. In the years since our engineers have worked tirelessly to develop a ventilator to meet all of Neonatal Rescue’s goals: a portable ventilator that was affordable and had battery-powered capabilities. In 2020 as the COVID-19 pandemic strained the medical system. Neonatal Rescue knew that we had to help and knew we could. We adapted our existing newborn ventilator to accommodate adult patients with COVID-19. We submitted the modified device for FDA approval and received FDA Emergency Use Authorization in June 2020. While we are proud of our adult adaptation, Neonatal care has always been at the forefront of our minds.
Neonatal Rescue is now pursuing permanent FDA approval for our NeoLife ventilator. With each submission for approval, Neonatal must provide information about the device and how it works, provide evidence of safe and controlled testing, and documented data about the device’s function. The NeoLife Ventilator is a Class II device, meaning it is subject to a specific set of guidelines to ensure the device is safe for use. As we received feedback from the FDA. We constantly improve our devices so they can be as safe and effective as possible. As we make our way through this process, we express our gratitude to our donors who support our hardworking engineers and us.