{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-23-036843","form_type":"8-K","ticker":"TNDM","cik":"0001438133","company_name":"TANDEM DIABETES CARE INC","filed_at":"2023-11-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.082784+00:00","generated_at":"2026-06-08T19:35:41.563461+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Tandem Diabetes receives FDA clearance for t:slim X2 pump and Control-IQ for children 2+","bullets":["FDA cleared 510(k) applications for t:slim X2 insulin pump and Control-IQ technology enhancements on Nov 3, 2023.","Expanded pediatric indication now includes individuals two years of age and older.","This clearance broadens the eligible patient population for Tandem's automated insulin delivery system."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-23-036843","json":"https://secwatch.observer/filing/0001628280-23-036843.json","markdown":"https://secwatch.observer/filing/0001628280-23-036843.md","text":"https://secwatch.observer/filing/0001628280-23-036843.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1438133/000162828023036843/0001628280-23-036843-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1438133/000162828023036843/tndm-20231103.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-08T19:35:41.563461+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"}