News
Australian Company Spray-on-Skin Treatment for Burns Closer to Receive FDA Approval
The US regulator has now given the company permission to apply for early regulatory approval for its spray-on skin technology. The ruling falls under new FDA guidelines, which are aimed at helping patients get more timely access to lifesaving medical devices.
“The FDA’s decision that we meet the criteria tallies with our view that ReCell is a unique offering for helping burns victims, and as such, approval would be preferable sooner than later,” said Andrew Quick, Avita’s vice president of research and technology.
“We are excited that we can now advance discussions with the agency to determine exactly how this changes our time frames,” he added.
Source: Medindia
Source link
#Australian #Company #SprayonSkin #Treatment #Burns #Closer #Receive #FDA #Approval
