{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-030638","form_type":"8-K","ticker":"FEMY","cik":"0001339005","company_name":"FEMASYS INC","filed_at":"2024-06-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.015779+00:00","generated_at":"2026-06-01T03:16:55.840746+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 four women's health products, enters EU market","bullets":["Received EU MDR certificate and CE Mark for FemaSeed, FemVue, FemCerv, FemCath.","Approvals allow Femasys to begin marketing all four products in the European Union.","CEO Kathy Lee-Sepsick: CE Mark validates commitment to highest quality and safety standards.","Company will identify strategic distribution partners to commercialize products throughout the EU.","Initial US commercial team build-out completed; EU expansion follows CE Mark approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-030638","json":"https://secwatch.observer/filing/0001140361-24-030638.json","markdown":"https://secwatch.observer/filing/0001140361-24-030638.md","text":"https://secwatch.observer/filing/0001140361-24-030638.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1339005/000114036124030638/0001140361-24-030638-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1339005/000114036124030638/ef20031386_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T03:16:55.840746+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"}