---
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"
generated_at: "2026-05-31T23:03:01.702526+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 Breakthrough Device Designation for nsPFA Cardiac Surgery System for AF treatment

## Summary
- 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.

## SEC filing metadata
- 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
- 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/1625101/000143774924022297/0001437749-24-022297-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1625101/000143774924022297/plse20240708_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-022297
- JSON: https://secwatch.observer/filing/0001437749-24-022297.json
- Plain text: https://secwatch.observer/filing/0001437749-24-022297.txt

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