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AVITA Medical Announces FDA Approval of New …

    https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-announces-fda-approval-new-recellr-system-improved
    VALENCIA, Calif. and MELBOURNE, Australia, Feb. 17, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that …

U.S. Food and Drug Administration Approves Expanded …

    https://ir.avitamedical.com/news-releases/news-release-details/us-food-and-drug-administration-approves-expanded-use-recellr
    VALENCIA, Calif. and MELBOURNE, Australia, June 10, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company …

AVITA Medical Announces FDA Approval of New …

    https://www.globenewswire.com/news-release/2022/02/17/2387555/0/en/AVITA-Medical-Announces-FDA-Approval-of-New-RECELL-System-with-Improved-Ease-of-Use.html
    AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018 and a new ease-of-use …

AVITA Medical Submits FDA PMA Supplement to …

    https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-submits-fda-pma-supplement-further-expand
    VALENCIA, Calif., and MELBOURNE, Australia, Dec. 12, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company …

AVITA Medical Submits FDA PMA Application to Expand

    https://www.globenewswire.com/en/news-release/2022/12/19/2576253/0/en/AVITA-Medical-Submits-FDA-PMA-Application-to-Expand-Indication-to-Vitiligo.html
    VALENCIA, Calif., and MELBOURNE, Australia, Dec. 19, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative …

AVITA Medical Submits FDA PMA Application to Expand …

    https://finance.yahoo.com/news/avita-medical-submits-fda-pma-130000404.html
    VALENCIA, Calif., and MELBOURNE, Australia, Dec. 19, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative …

RECELL Autologous Cell Harvesting Device | FDA

    https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/recell-autologous-cell-harvesting-device
    June 9, 2021 Approval Order - RECELL Autologous Cell Harvesting Device September 20, 2018 Approval Order - RECELL Autologous Cell Harvesting Device Summary of Safety …

AVITA Medical Announces FDA Approval of the …

    https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-announces-fda-approval-recellr-system-treatment
    Valencia, Calif., USA, and Melbourne, Australia, 21 September 2018 — AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, today …

AVITA Medical Receives U.S. FDA Investigational …

    https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-receives-us-fda-investigational-device-exemption-0
    Valencia, Calif., USA, and Melbourne, Australia, 17 September 2019 — AVITA Medical (ASX: AVH, OTCQX: AVMXY), a regenerative medicine company focused on the …

September 20, 2018 Avita Medical Americas, LLC …

    https://www.fda.gov/media/116379/download
    Avita will perform Assay validation (specificity, accuracy, linearity, repeatability, intermediate precision, range, and ruggedness) at each laboratory that conducts the …



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