{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-023561","form_type":"8-K","ticker":"FEMY","cik":"0001339005","company_name":"FEMASYS INC","filed_at":"2025-06-25T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.018278+00:00","generated_at":"2026-05-18T19:06:49.248691+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Femasys receives CE mark for FemBloc, first non-surgical permanent birth control, for European market","bullets":["CE mark certification for entire FemBloc System under EU MDR 2017/745; can now be marketed in European Economic Area (27 EU + 3 EFTA states).","Follows earlier March 13, 2025 delivery system approval; combined approval marks first global regulatory endorsement.","Company plans initial commercial launch in Spain via existing distribution partnerships; also seeking additional country approvals.","FemBloc is a non-surgical permanent birth control alternative; U.S. FDA IDE pivotal trial continues enrollment for U.S. approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-023561","json":"https://secwatch.observer/filing/0001140361-25-023561.json","markdown":"https://secwatch.observer/filing/0001140361-25-023561.md","text":"https://secwatch.observer/filing/0001140361-25-023561.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1339005/000114036125023561/0001140361-25-023561-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1339005/000114036125023561/ef20050990_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T19:06:49.248691+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"}