NASA, Fitbit get FDA approval for ventilators designed to help COVID-19 patients

US Food and Drug Administration (FDA) has given emergency use authorisation (EUA) to ventilator and resuscitator developed by NASA and Fitbit respectively. The federal agency added a second ventilator developed by NASA to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the EUA.

The expedited approval has been issued due to insufficient supply and availability of FDA-cleared ventilators for use in health care facilities to treat COVID-19 patients. According to the FDA, NASA’s VITAL (Ventilator Intervention Technology Accessible Locally) is intended to last three to four months and is specifically tailored to provide respiratory support for COVID-19 patients.

The first NASA ventilator, approved on April 30, relied on wall gas as the pressure source while the second ventilator uses an internal compressor for its energy source. The device does not impact the existing supply chain since it is designed to be built with components outside the current medical device supply chain.

“The VITAL Compressor ventilator is a restricted medical device intended for use by qualified healthcare provider who understands the functionality of the device operating under the direction of a physician,” reads an FDA document.

Read: Donald Trump Speaks To PM Modi, Says 'US To Ship 100 Donated Ventilators By Next Week'

Fitbit Flow

The emergency resuscitator developed by Fitbit is an accessory with audible and visual alarms that aid the performance of the manual resuscitator for continuous breathing. The design is intended for use in treating patients with COVID-19. The Fitbit Flow supports conventional Volume Control and Pressure Control modes of ventilation, as well as an “Assist Control” feature to support breaths triggered by the patient. 

Meanwhile, US State Department announced that three Indian companies have been given licenses by  NASA's Jet Propulsion Laboratory (JPL) in Southern California for manufacturing the new ventilator that uses one-seventh the parts of a traditional ventilator, designed for coronavirus patients. The three companies selected are Alpha Design Technologies, Bharat Forge and Medha Servo Drives.

Read: Four-member Panel To Probe Alleged Irregularities In Purchase Of Ventilators In Himachal

(Image Credit: NASA)