Institute of Good Manufacturing Practices India®

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Avita obtains FDA approval for cell harvesting device Recell GO System

Avita Medical has received FDA approval for its next-generation autologous cell harvesting device, the Recell GO System, designed for burns and skin defects. This system treats thermal burn wounds and full-thickness skin defects using the patient's own skin cells. Enhanced features simplify cell preparation, reducing training requirements and improving workflow efficiency. By controlling Recell Enzyme incubation time, the device ensures optimal cell yield and viability, enhancing user experience. FDA approval signifies a significant advancement in wound treatment. With Recell GO, clinicians can efficiently treat more patients, extending the proven benefits of Recell technology. The system will launch in leading US burn treatment centers next month, gradually expanding to other accounts. Recell GO is versatile, promoting healing in various applications, including full-thickness skin defects, burns, and vitiligo.