This section highlights FDA-related milestones and regulatory updates for drugs developed by Pulse Biosciences (PLSE).
Over the past two years, Pulse Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CellFX and nsPFA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
CellFX FDA Regulatory Events
CellFX is a drug developed by Pulse Biosciences for the following indication: General dermatologic conditions.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CellFX
- Announced Date:
- July 8, 2024
- Indication:
- General dermatologic conditions
Announcement
Pulse Biosciences, Inc announced that it has received the Breakthrough Device Designation from the U.S. FDA for the Company's Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation (AF).
AI Summary
Pulse Biosciences, Inc. has received the Breakthrough Device Designation from the U.S. FDA for its Cardiac Surgery System. The system uses the company's proprietary nanosecond Pulsed Field Ablation (nsPFA) technology to treat atrial fibrillation by ablating cardiac tissue. This designation means that the device has the potential to offer significant benefits over current treatments. It is designed to create rapid, durable, and continuous transmural ablation lesions during cardiac surgery, requiring less than 2 seconds for a single application. The non-thermal mechanism of nsPFA reduces the risk of damaging surrounding tissues compared to traditional thermal ablation methods.
The FDA’s Breakthrough Device Program provides expanded access and speeds up the review process, which will help bring this innovative treatment for atrial fibrillation to patients and surgeons more quickly.
Read Announcement
NsPFA FDA Regulatory Events
NsPFA is a drug developed by Pulse Biosciences for the following indication: Treatment of Atrial Fibrillation.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- nsPFA
- Announced Date:
- September 8, 2025
- Indication:
- Treatment of Atrial Fibrillation
Announcement
Pulse Biosciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company's Investigational Device Exemption (IDE), allowing Pulse Biosciences to proceed with the initiation of its nsPFA Cardiac Surgery System Study, NANOCLAMP AF, for the treatment of atrial fibrillation (AF).
AI Summary
Pulse Biosciences announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) for its nsPFA Cardiac Surgery System Study, NANOCLAMP AF, to treat atrial fibrillation. This approval clears the way to begin enrolling patients and collecting safety and effectiveness data.
This single-arm, prospective study will run at up to 20 sites—18 U.S. and two international—and enroll 136 patients during concomitant cardiac surgeries. Its primary goal is to show that the nsPFA Cardiac Clamp can create durable, full-thickness lesions that prevent AF recurrence. More details will appear on ClinicalTrials.gov.
The nsPFA Cardiac Clamp uses proprietary nonthermal nanosecond pulses to deliver continuous linear, transmural ablations. By avoiding heat, it may minimize collateral tissue damage and shorten procedure times compared with thermal radiofrequency ablation.
FDA IDE approval is a major milestone for Pulse Biosciences. The company expects to enroll its first patients soon and build real-world evidence to support broader adoption of this new cardiac ablation technology.
Read Announcement
