{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-040514","form_type":"8-K","ticker":"FEMY","cik":"0001339005","company_name":"FEMASYS INC","filed_at":"2024-09-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:12.715115+00:00","generated_at":"2026-05-31T05:51:45.444387+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 FDA 510(k) clearance for FemChec fallopian tube diagnostic","bullets":["FemChec cleared by FDA for controlled contrast delivery to check tubal status.","FemChec is also used as confirmation test after FemBloc non-surgical permanent birth control.","FemBloc is in late-stage FINALE pivotal trial, currently enrolling.","FemChec uses natural contrast and ultrasound, avoiding x-ray dye and radiation exposure.","CEO Kathy Lee-Sepsick says clearance strengthens women's health product suite."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-040514","json":"https://secwatch.observer/filing/0001140361-24-040514.json","markdown":"https://secwatch.observer/filing/0001140361-24-040514.md","text":"https://secwatch.observer/filing/0001140361-24-040514.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1339005/000114036124040514/0001140361-24-040514-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1339005/000114036124040514/ef20035640_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T05:51:45.444387+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"}