This device has been authorized by the FDA for Emergency Use (EUA) during the Coronavirus Disease (COVID-19) pandemic.  The FDA definition of the device is a Continuous Ventilator for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency.  The Intended Use of the iBreeze PAP system is to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing over 30kg (66 lbs) for use in the home, hospital, or institutional environment.

For more information on the EUA, visit

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/ventilators-and-ventilator-accessories-euas#ventilators

For facts of the known and unknown risks and benefits of the emergency use, visit

 https://www.fda.gov/media/136424/download