In response to the COVID-19 crisis, the FDA has issued emergency use authorizations (EUAs) for ventilator-related devices to Lombardi Undersea, Middletown, R.I.; Vortran Medical Technology 1, Sacramento, Calif.; and Nanotronics Imaging, Cuyahoga Falls, Ohio.
Lombardi Undersea’s Subsalve Oxygen Treatment Hood is a patient interface intended for helmet-based Non-Invasive Positive Pressure Ventilation, according to clinician-established protocols to treat Acute Respiratory Distress Symptoms resulting from COVID-19. The device is for use with adult patients only in Intensive Care Unit settings.
Vortran Medical Technology 1’s Vortran Go2Vent with PEEP Valve is intended for use by properly trained personnel to deliver emergency, short term, constant-flow pressure-cycled ventilator support with patients who weigh 10kg or more.
Nanotronics Imaging’s nHale device provides bi-level positive air pressure to support respiratory therapy of spontaneously breathing adults who weigh more than 30kg and who suffer from COVID-19 disease in traditional healthcare facilities (e.g., hospitals, assisted living facilities, nursing homes), private homes, as well as spaces converted for the care of large numbers of COVID-19 patients (e.g., convention centers, university dormitories, motels).
