The device features high-flow oxygen therapy and can be used for both invasive and non-invasive ventilation under Emergency Use Authorization from the FDA due to shortages from the COVID-19 pandemic.
Movair said it is filing for permanent 510(k) FDA clearance for the Luisa by the end of 2021.
The device weighs 8 lb and can run for up to 18 hours on battery power, Movair said yesterday in a news release.
“Increased respiratory patient illness, COVID-19 and product recalls have created a critical need for ventilators in the United States,” Movair CEO David Shockley said in the news release. “We’re addressing this demand with the launch of Luisa, a por…