{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-038213","form_type":"8-K","ticker":"PLSE","cik":"0001625101","company_name":"PULSE BIOSCIENCES, INC.","filed_at":"2025-12-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.963909+00:00","generated_at":"2026-05-16T12:44:52.792561+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Pulse Biosciences receives FDA IDE approval to initiate NANOPULSE-AF clinical study for paroxysmal atrial fibrillation","bullets":["FDA approved IDE for Pulse Biosciences' nPulse Cardiac Catheter System to treat paroxysmal atrial fibrillation in NANOPULSE-AF study.","Study is single-arm, multicenter, prospective; up to 30 sites (3 outside US) and up to 145 patients planned.","Ongoing European feasibility study has enrolled 150 patients; positive initial outcomes support device's potential.","nPulse uses nanosecond PFA aiming for complete circumferential lesion in single energy application without stacking.","CEO Paul LaViolette calls FDA approval a major milestone; follow-up data expected in 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-038213","json":"https://secwatch.observer/filing/0001437749-25-038213.json","markdown":"https://secwatch.observer/filing/0001437749-25-038213.md","text":"https://secwatch.observer/filing/0001437749-25-038213.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1625101/000143774925038213/0001437749-25-038213-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1625101/000143774925038213/plse20251218_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:44:52.792561+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"}