![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Avita Medical Wins CE Mark for New ReCell Device
Avita Medical Wins CE Mark for New ReCell Device
![Avita-Medical-pic.jpg](https://www.fdanews.com/ext/resources/test/Device_Images4/Avita-Medical-pic.jpg?t=1578337135&width=430)
Avita Medical plans to launch its second generation ReCell burn treatment device in Europe, following CE Mark approval, the UK devicemaker announced Monday.
The new model can treat up to a 1,920 square-centimeter surface area and features a six-fold greater coverage than the first generation device — the original ReCell could treat only 320 square centimeters. The new generation is designed for burn victims requiring heavier-duty grafts, the company said.
ReCell is TGA-registered in Australia and SFDA-cleared in China. It is limited to investigational use in the U.S. while an FDA Phase III trial is underway.
Avita Medical markets wounds, scars and skin defects products. — Jason Scott
Upcoming Events
-
21Oct