Louisville medical device company gets emergency FDA approval

By Chris Larson

Louisville-based Liberate Medical LLC received an emergency use authorization from the Food and Drug Administration to market its core product, VentFree, during the coronavirus crisis, Louisville Business First reports.

VentFree aims to prevent breathing muscles from degrading while patients are on a ventilator. The approval will last as long as the federal government determines that emergency circumstances still justify using a treatment that has not otherwise been approved for use by the FDA, according to a news release.

Liberate Medical is in talks with manufacturers in Minnesota, Ohio and Iowa to ramp up production and expedite distribution to hospitals nationwide.

CEO and co-founder Angus McLachlan has said that the company will still pursue approval through the FDA’s “Breakthrough Device” designation track. The company received the designation in January 2019. He said that if the company can get approval through this track during the emergency use authorization, Liberate Medical would continue marketing VentFree in the U.S.