Avita Medical Gets Premarket Approval for New Version of its Recell Device
Avita Medical has received a supplemental premarket approval from the FDA for the newest version of its Recell autologous cell-harvesting device.
The system, which is intended to treat acute thermal burns, enables healthcare professionals to produce a suspension of spray-on skin cells using a small sample of the patient’s own skin.
The new version of the device has been modified to reduce setup steps by approximately one-third and to enable its use with fewer support personnel, the company said.
Avita plans to start marketing the Recell system in the U.S. in the second quarter of 2022.