The FDA granted emergency use authorization (EUA) for emergency COVID-19 ventilator devices developed by Nasa and Fitbit (NYSE:FIT).
According to the FDA’s ongoing list of devices granted EUAs, both devices were authorized on June 1. NASA’s VITAL (ventilator intervention technology accessible locally) compressor and the Fitbit Flow are the latest of a few ventilator alternatives to garner EUA status.
NASA’s VITAL compressor is designed to offer continuous ventilatory support for adult patients requiring ventilation when no standard ventilators are available. It is a restricted device intended for use by a qualified healthcare provider.
The VITAL compressor is the second NASA ventilator to earn EUA, after the original VITAL device obtained authorization last month. NASA touts VITAL as capable of being built faster and maintained more easily than a traditional ventilator. The device includes fewer parts than other ventilators, many of which NASA says are available through existing supply chains. Its design can be modified for use in field hospitals set up in high-capacity facilities.
Fitbit Flow is listed by the FDA as an emergency resuscitator and is indicated for the continuous mechanical ventilatory support of adult patients. It is described in the FDA list as an accessory to a manual resuscitator, featuring a reusable mechanical actuator and single-use, disposable tubing assembly.
The device supports conventional volume control and pressure control modes of ventilation, along with an “assist control” feature that supports breaths triggered by the patient. Like NASA’s ventilator, the Fitbit Flow is intended for use by qualified, trained personnel only when an FDA-cleared clinical ventilator is unavailable during the COVID-19 pandemic.