{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-039138","form_type":"8-K","ticker":"FEMY","cik":"0001339005","company_name":"FEMASYS INC","filed_at":"2024-08-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:12.714504+00:00","generated_at":"2026-05-31T06:57:54.473712+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Femasys receives CE Mark and Health Canada approval for FemVue MINI fallopian tube assessment","bullets":["CE Mark certification obtained for FemVue MINI, enabling sales in European Economic Area.","Health Canada granted product approval for FemVue MINI, opening Canadian market.","FemVue MINI is a compact, eco-friendly version of existing FemVue diagnostic product.","CEO Kathy Lee-Sepsick cites expanded access to advanced women's health diagnostics in Europe and Canada.","Product designed with smaller environmental footprint, supporting company sustainability initiatives."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-039138","json":"https://secwatch.observer/filing/0001140361-24-039138.json","markdown":"https://secwatch.observer/filing/0001140361-24-039138.md","text":"https://secwatch.observer/filing/0001140361-24-039138.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1339005/000114036124039138/0001140361-24-039138-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1339005/000114036124039138/ef20035123_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T06:57:54.473712+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"}