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BioWorld - Tuesday, November 18, 2025
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Home » Avita’s Recell gains FDA greenlight for skin repigmentation in vitiligo
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Avita’s Recell gains FDA greenlight for skin repigmentation in vitiligo

June 21, 2023
By Tamra Sami
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
BioWorld MedTech Medical devices and technologies Regulatory Dermatologic Australia U.S. FDA PMA

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