{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-022297","form_type":"8-K","ticker":"PLSE","cik":"0001625101","company_name":"PULSE BIOSCIENCES, INC.","filed_at":"2024-07-08T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.851695+00:00","generated_at":"2026-05-31T23:03:01.702526+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 Breakthrough Device Designation for nsPFA Cardiac Surgery System for AF treatment","bullets":["FDA Breakthrough Device Designation for CellFX nsPFA Cardiac Surgery System to treat atrial fibrillation.","Designation provides expedited development and prioritized review; company plans PMA approval pathway.","Preclinical data shows single <2-second application creates transmural ablation, ~20x faster than thermal RF.","First-in-human cases expected in Netherlands soon; pivotal clinical trial planned for 2025.","No risk of thermal spread due to non-thermal nano-PFA mechanism, potentially safer than current options."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-022297","json":"https://secwatch.observer/filing/0001437749-24-022297.json","markdown":"https://secwatch.observer/filing/0001437749-24-022297.md","text":"https://secwatch.observer/filing/0001437749-24-022297.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1625101/000143774924022297/0001437749-24-022297-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1625101/000143774924022297/plse20240708_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T23:03:01.702526+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"}