{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-081410","form_type":"8-K","ticker":"HSCS","cik":"0001468492","company_name":"HeartSciences Inc.","filed_at":"2025-06-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.388987+00:00","generated_at":"2026-05-19T23:48:16.107285+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"HeartSciences gets FDA Breakthrough Device designation for AI-ECG algorithm detecting aortic stenosis","bullets":["FDA granted Breakthrough Device designation for HeartSciences' Aortic Stenosis AI-ECG algorithm.","Algorithm detects moderate-to-severe aortic stenosis via MyoVista Insights cloud platform integrated with EHR.","Trained on >120,000 ECG records; can detect AS up to 24 months before echocardiography.","No additional hardware required; uses existing ECG data for real-time or retrospective analysis."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-081410","json":"https://secwatch.observer/filing/0000950170-25-081410.json","markdown":"https://secwatch.observer/filing/0000950170-25-081410.md","text":"https://secwatch.observer/filing/0000950170-25-081410.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1468492/000095017025081410/0000950170-25-081410-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1468492/000095017025081410/hscs-20250604.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T23:48:16.107285+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"}