Avita Medical gets FDA approval for Recell device
Singapore, Jan. 3 -- UK based AVITA Medical Limited, a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration has announced that the U.S. Food and Drug Administration (FDA) has approved the company's Investigational Device Exemption (IDE) application to conduct a feasibility study evaluating the safety and effectiveness of the RECELL(R) Autologous Cell Harvesting Device (RECELL(R) System) for repigmentation of depigmented lesions associated with stable vitiligo. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe
"Vitiligo affects approximately 6.5 million people in the United States(i) , rivalling the prevalence of psoriasis(...
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