FDA approves widely available non-invasive ventilator for emergency use at home during the COVID-19 pandemic

As knowledge of COVID-19 progresses, medical professionals and the public have become aware of how crucial non-invasive ventilation is for COVID-19 patient care in hospital and at home. To meet this need, Nanotronics Health conceived, designed and manufactured a non-invasive ventilator in under 90 days. The device, nhale, has obtained Emergency Use Authorization (EUA) from the US Food & Drug Administration (FDA) for at-home use. Nanotronics Health also received authorization for the nHale to be used with supplemental oxygen under a doctor’s prescription. This approval provides flexibility for home care solutions and treatment, especially in the COVID-19 era.

According to Julie Orlando, President of Nanotronics Health, “Non-invasive ventilation is essential to aid the treatment of COVID-19. Around the world, there is an immediate need to shore up relief in hospitals (and homes) as medical professionals struggle to successfully treat the massive influx of patients in respiratory distress. My company is striving to bridge this gap with nHale, which serves adult patients suffering from COVID-19.” Orlando further goes on to add, “I envision the nHale will continue to serve after the crisis. We want to deploy to countries who can’t afford high-cost medical care beyond COVID-19, for pneumonia, COPD, and other illnesses. The nHale design is about capability, flexibility, and puts the user first.”

 

Easy to use and flexible

With a one-button approach, the device is designed for quality, comfort, and ease of use. According to Orlando, “We wanted to provide hospitals and consumers with an affordable respiratory option to promote healing and aid the treatment of COVID-19. An innovative manufacturing vision was essential for building and scaling this critical device quickly—to get it in the hands of those who need it most.”

This non-invasive ventilator is designed to assist spontaneously breathing adults suffering from COVID-19 disease. It is intended for use in non-life-threatening situations, such as when a patient is in need of breathing assistance but not in need of invasive ventilatory support based on standard medical protocols. Supplemental oxygen can be used with the nHale device to increase the oxygen concentration of the airflow being delivered to the patient only when prescribed and trained by a qualified medical professional. The warnings must be observed when using supplemental oxygen with the nHale device.

Who stands to benefit?

This is a bi-level positive air pressure device that can support respiratory therapy of spontaneously breathing adults weighing over 30kg suffering from COVID-19 disease. It is a non-invasive ventilator designed to be used in non-life-threatening situations, for spontaneously breathing patients, such as a patient in need of breathing assistance but not in need of invasive ventilatory support based on standard medical protocols. The machine is intended for use in hospitals, assisted living facilities, nursing homes, care centres and also private homes.

Is it also meant for people with severe COVID complications?

nHale assists spontaneously breathing adults suffering from COVID-19 disease. It is intended for use in non-life-threatening situations only, such as when a patient is in need of breathing assistance but not in need of invasive ventilatory support based on standard medical protocols.