{"schema_version":"secwatch.filing_event.v1","accession":"0001438133-25-000160","form_type":"8-K","ticker":"TNDM","cik":"0001438133","company_name":"TANDEM DIABETES CARE INC","filed_at":"2025-08-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.997269+00:00","generated_at":"2026-05-17T17:21:01.855121+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Tandem Diabetes receives FDA 510(k) clearance for SteadiSet infusion set for 7-day use","bullets":["FDA cleared SteadiSet infusion set for up to seven days of use; features integrated inserter with hidden needle.","SteadiSet designed for type 1 diabetes patients; will be standalone for t:slim X2 and Tandem Mobi pumps.","Also component of future Tandem Mobi tubeless insulin delivery system; manufacturing scale-up underway.","Company expects to launch after scale-up; financial details in future earnings announcements."],"urls":{"canonical":"https://secwatch.observer/filing/0001438133-25-000160","json":"https://secwatch.observer/filing/0001438133-25-000160.json","markdown":"https://secwatch.observer/filing/0001438133-25-000160.md","text":"https://secwatch.observer/filing/0001438133-25-000160.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1438133/000143813325000160/0001438133-25-000160-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1438133/000143813325000160/tndm-20250806.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T17:21:01.855121+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"}