{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-013836","form_type":"8-K","ticker":"INBS","cik":"0001725430","company_name":"INTELLIGENT BIO SOLUTIONS INC.","filed_at":"2025-09-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.810744+00:00","generated_at":"2026-05-17T06:22:42.210929+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Intelligent Bio Solutions must resubmit FDA 510(k) for drug screening system after new info request","bullets":["FDA requested new additional information in a letter dated September 12, 2025, requiring a new 510(k) resubmission.","Company previously responded to a February 2025 AI request covering over 70 items and submitted additional data in August 2025.","First-of-its-kind sweat-based device; FDA feedback described as not uncommon for breakthrough technologies.","Company expects an investor update within ten days outlining a revised timeline for FDA clearance.","International commercial activities continue to grow outside the U.S. while pursuing clearance."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-013836","json":"https://secwatch.observer/filing/0001493152-25-013836.json","markdown":"https://secwatch.observer/filing/0001493152-25-013836.md","text":"https://secwatch.observer/filing/0001493152-25-013836.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1725430/000149315225013836/0001493152-25-013836-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1725430/000149315225013836/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:22:42.210929+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"}