---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-028560"
form_type: "8-K"
ticker: "PLSE"
cik: "0001625101"
company_name: "PULSE BIOSCIENCES, INC."
filed_at: "2025-09-08T23:59:59+00:00"
generated_at: "2026-05-17T07:36:46.040445+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Pulse Biosciences receives FDA IDE approval for nsPFA Cardiac Surgery Study NANOCLAMP AF

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-25-028560
- form_type: 8-K
- ticker: PLSE
- cik: 0001625101
- company_name: PULSE BIOSCIENCES, INC.
- filed_at: 2025-09-08T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1625101/000143774925028560/0001437749-25-028560-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1625101/000143774925028560/plse20250905_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-028560
- JSON: https://secwatch.observer/filing/0001437749-25-028560.json
- Plain text: https://secwatch.observer/filing/0001437749-25-028560.txt

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