{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-021706","form_type":"8-K","ticker":"GCTK","cik":"0001506983","company_name":"Glucotrack, Inc.","filed_at":"2026-05-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.389003+00:00","generated_at":"2026-05-14T21:37:10.702454+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Glucotrack submits IDE to FDA for US clinical study of implantable CBGM","bullets":["Glucotrack submitted an IDE application to the FDA to initiate a US clinical study of its fully implantable continuous blood glucose monitoring (CBGM) system.","CBGM is designed for 3-year sensor longevity, blood-based accuracy, and no on-body wearable component.","Company plans to proceed with US clinical study following FDA review and approval of the IDE.","IDE submission follows years of preclinical evaluation and iterative engineering; data support advancing to clinical evaluation.","CEO Paul Goode stated the submission reflects progress toward offering a discreet, accurate CGM option for diabetes patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-021706","json":"https://secwatch.observer/filing/0001493152-26-021706.json","markdown":"https://secwatch.observer/filing/0001493152-26-021706.md","text":"https://secwatch.observer/filing/0001493152-26-021706.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1506983/000149315226021706/0001493152-26-021706-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1506983/000149315226021706/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-14T21:37:10.702454+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"}