{"schema_version":"secwatch.filing_event.v1","accession":"0001641172-25-000626","form_type":"8-K","ticker":"INBS","cik":"0001725430","company_name":"INTELLIGENT BIO SOLUTIONS INC.","filed_at":"2025-03-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.630809+00:00","generated_at":"2026-05-24T05:53:03.352691+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Intelligent Bio Solutions' FDA clearance process on track for 2025 U.S. launch","bullets":["510(k) submitted Dec 18, 2024; FDA issued Additional Information request, pausing 90-day review clock.","Company responding to AI request; clearance expected within 3–6 months or longer if additional data needed.","System demonstrated 94.1% accuracy in method comparison study; PK data closely aligned to blood at 95% confidence level.","Targeting opiate test system for codeine; full panel already in 19 countries with over 400 accounts."],"urls":{"canonical":"https://secwatch.observer/filing/0001641172-25-000626","json":"https://secwatch.observer/filing/0001641172-25-000626.json","markdown":"https://secwatch.observer/filing/0001641172-25-000626.md","text":"https://secwatch.observer/filing/0001641172-25-000626.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1725430/000164117225000626/0001641172-25-000626-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1725430/000164117225000626/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T05:53:03.352691+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"}