AVITA Medical Announces FDA Breakthrough Device Designations for the RECELL® System
Retrieved on:
Friday, November 4, 2022
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Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase.
Key Points:
- Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase.
- We are pleased that the FDA has recognized the therapeutic potential of our RECELL System for our proposed soft tissue repair and vitiligo indications with the Breakthrough Device designations, said Jim Corbett, AVITA Medical Chief Executive Officer.
- AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018.
- In February 2022, the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow.