---
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"
generated_at: "2026-05-16T12:44:52.792561+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Pulse Biosciences receives FDA IDE approval to initiate NANOPULSE-AF clinical study for paroxysmal atrial fibrillation

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-038213
- JSON: https://secwatch.observer/filing/0001437749-25-038213.json
- Plain text: https://secwatch.observer/filing/0001437749-25-038213.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.