secwatch.observer — SEC 8-K summary
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Issuer:     PULSE BIOSCIENCES, INC. (PLSE)
CIK:        0001625101
Form:       8-K
Filed at:   2025-09-08T23:59:59+00:00
Accession:  0001437749-25-028560
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Pulse Biosciences receives FDA IDE approval for nsPFA Cardiac Surgery Study NANOCLAMP AF
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- FDA granted IDE approval for the NANOCLAMP AF study of nsPFA Cardiac Surgical System to treat atrial fibrillation.
- Single-arm prospective study plans up to 20 sites (2 outside U.S.) enrolling up to 136 patients.
- First-in-human EU feasibility study (since Aug 2024) treated over 40 patients with ablation times as short as 2.5 seconds.
- nsPFA Cardiac Clamp received FDA Breakthrough Device Designation in July 2024 and is enrolled in the TAP program.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1625101/000143774925028560/0001437749-25-028560-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1625101/000143774925028560/plse20250905_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-028560

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer