{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-050935","form_type":"8-K","ticker":"RCEL","cik":"0001762303","company_name":"AVITA Medical, Inc.","filed_at":"2023-10-02T23:59:59+00:00","discovered_at":"2026-05-14T18:03:30.350235+00:00","generated_at":"2026-06-10T06:26:48.467320+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"AVITA Medical receives FDA additional info request for RECELL GO PMA; launch pushed to mid-2024","bullets":["FDA placed RECELL GO PMA supplement on hold for ~4-6 months pending additional info.","Review will resume 180-day cycle upon complete response, with 90 days remaining.","Implied product launch is now between May 1 and July 1, 2024.","PMA was submitted June 30, 2023 under Breakthrough Device program.","Company received notice at halfway point of the 180-day review cycle."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-050935","json":"https://secwatch.observer/filing/0000950170-23-050935.json","markdown":"https://secwatch.observer/filing/0000950170-23-050935.md","text":"https://secwatch.observer/filing/0000950170-23-050935.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1762303/000095017023050935/0000950170-23-050935-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1762303/000095017023050935/rcel-20231002.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T06:26:48.467320+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}