{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-008559","form_type":"8-K","ticker":"FEMY","cik":"0001339005","company_name":"FEMASYS INC","filed_at":"2025-03-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.386505+00:00","generated_at":"2026-05-24T20:38:01.259265+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Femasys gets CE mark for FemBloc delivery system in Europe, polymer approval expected mid-2025","bullets":["FemBloc delivery system receives first-in-world CE mark certification under EU MDR for non-surgical permanent birth control.","FemBloc blended polymer completes G12 Special MDR Audit; Notified Body recommends CE mark pending EMA review, approval expected mid-2025.","Company continues enrolling participants in FDA IDE-approved pivotal clinical trial for U.S. approval of FemBloc.","CEO Kathy Lee-Sepsick highlights FemBloc as a safer, accessible alternative to surgical sterilization, the only option today."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-008559","json":"https://secwatch.observer/filing/0001140361-25-008559.json","markdown":"https://secwatch.observer/filing/0001140361-25-008559.md","text":"https://secwatch.observer/filing/0001140361-25-008559.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1339005/000114036125008559/0001140361-25-008559-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1339005/000114036125008559/ef20045446_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T20:38:01.259265+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"}