{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-045950","form_type":"8-K","ticker":"FEMY","cik":"0001339005","company_name":"FEMASYS INC","filed_at":"2025-12-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.188749+00:00","generated_at":"2026-05-16T12:43:03.532019+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 receives FDA 510(k) clearance for next-gen FemVue Controlled device","bullets":["FDA 510(k) clearance for FemVue Controlled, integrating FemVue and FemChec technologies.","Single-device solution for controlled contrast delivery to evaluate fallopian tube status.","Designed to enable multiple clinical uses and streamline manufacturing and practice workflows.","CEO Kathy Lee-Sepsick highlights milestone as advancing clinician-focused innovations.","NASDAQ-ticker FEMY; clearance announced December 18, 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-045950","json":"https://secwatch.observer/filing/0001140361-25-045950.json","markdown":"https://secwatch.observer/filing/0001140361-25-045950.md","text":"https://secwatch.observer/filing/0001140361-25-045950.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1339005/000114036125045950/0001140361-25-045950-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1339005/000114036125045950/ef20061522_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:43:03.532019+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"}