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
nsPFA, nPulse™, and CellFX. 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.
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:
- April 25, 2026
- Indication:
- Treatment of Atrial Fibrillation
Announcement
Pulse Biosciences, Inc announced late-breaking positive clinical data from its nPulse Cardiac Catheter System first-in-human feasibility study at the Heart Rhythm 2026 meeting..
AI Summary
Pulse Biosciences announced late-breaking positive clinical data from its first-in-human feasibility study of the nPulse Cardiac Catheter System at the Heart Rhythm 2026 meeting. The system uses the company’s Nanosecond Pulsed Field Ablation (nsPFA) technology and was evaluated in a multicenter study in patients with atrial fibrillation.
The incremental follow-up presentation expanded the 6-month cohort to 95 subjects (from 75) and the 12-month cohort to 53 subjects (from 47). Investigators reported sustained high durability and strong procedural efficiency across the study, findings the company says help redefine expectations for catheter ablation. The late-breaking session also highlighted key outcomes from a 5-second ablation cohort, with positive signals supporting the approach.
Overall, the data support continued clinical development of the nPulse system and suggest potential for faster procedures with durable results for patients undergoing catheter ablation for atrial fibrillation. Further study and longer follow-up were noted as next steps.
Read Announcement- 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
NPulse™ Cardiac Surgical System FDA Regulatory Timeline and Events
NPulse™ Cardiac Surgical System is a drug developed by Pulse Biosciences for the following indication: treatment of atrial fibrillation (AF).
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:
- nPulse™ Cardiac Surgical System
- Announced Date:
- March 12, 2026
- Indication:
- treatment of atrial fibrillation (AF)
Announcement
Pulse Biosciences, Inc announced first patient enrollments in the multi-center first-in-human feasibility study of the Company's nPulse™ Vybrance™ Percutaneous Electrode System for treatment of T1N0M0papillary thyroid microcarcinoma (PTM), a small, slow-growing, and most common form of thyroid cancer.
AI Summary
Pulse Biosciences announced that the first patients have been enrolled in a multi-center, first-in-human feasibility study of its nPulse Vybrance Percutaneous Electrode System. The company says this study marks the initial clinical testing of the device in people.
The trial will evaluate the feasibility and safety of the nPulse Vybrance system for treatment of T1N0M0 papillary thyroid microcarcinoma (PTM). PTM is a small, slow-growing, and the most common form of thyroid cancer. The study is being conducted at multiple sites to gather early human data on how the device performs.
These initial enrollments start the clinical phase for the technology and will inform whether larger studies are needed to assess effectiveness and broader patient use.
Read Announcement- Drug:
- nPulse™ Cardiac Surgical System
- Announced Date:
- March 9, 2026
- Indication:
- treatment of atrial fibrillation (AF)
Announcement
Pulse Biosciences, Inc. announced clinical data on outcomes durability from the nPulse Vybrance Percutaneous Electrode System First-in-Human ablation study of benign thyroid nodules using nsPFA energy.
AI Summary
Pulse Biosciences announced long-term clinical results from its First-in-Human study of the nPulse Vybrance Percutaneous Electrode System using nanosecond pulsed field ablation (nsPFA) to treat benign thyroid nodules. The follow-up at 15–22 months showed an average nodule volume reduction of 74% among treated lesions. Investigators reported no tissue regrowth and no serious adverse events, and the data were presented by Prof. Stefano Spiezia at the North American Society for Interventional Thyroidology meeting in March 2026.
The company says these durable outcomes reflect features that distinguish nsPFA from other pulse field ablation methods, notably the speed of particle flow and high voltage pressure per unit time. These First-in-Human results suggest nsPFA may offer a fast, effective, and lasting minimally invasive option for reducing benign thyroid nodules, though larger studies will be needed to confirm safety and effectiveness.
Read Announcement- Drug:
- nPulse™ Cardiac Surgical System
- Announced Date:
- February 5, 2026
- Indication:
- treatment of atrial fibrillation (AF)
Announcement
Pulse Biosciences, Inc announced late-breaking clinical data from the nPulse Cardiac Catheter first-in-human feasibility study.
AI Summary
Pulse Biosciences announced late-breaking clinical data from the first‑in‑human feasibility study of its nPulse Cardiac Catheter. The company presented results assessing the device’s early performance and patient outcomes over follow-up periods, signaling progress in translating the technology into cardiac procedures.
Key reported outcomes showed procedural success in 100% of evaluable patients at six months and 96% at 12 months. Pulse highlighted additional study findings during the presentation but did not list them in the excerpt provided. These early, human feasibility results indicate the nPulse catheter can be delivered and used in patients with high short‑term procedural success; longer and larger studies will be needed to confirm safety, durability, and broader effectiveness.
Read Announcement- Drug:
- nPulse™ Cardiac Surgical System
- Announced Date:
- December 18, 2025
- Indication:
- treatment of atrial fibrillation (AF)
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 nPulse Cardiac Catheter Ablation System Study (NANOPULSE-AF) for the treatment of paroxysmal atrial fibrillation (PAF).
AI Summary
Pulse Biosciences announced that the U.S. FDA has approved its Investigational Device Exemption (IDE), clearing the way to start the NANOPULSE-AF study of the nPulse Cardiac Catheter Ablation System to treat paroxysmal atrial fibrillation (PAF). The single-arm, multicenter, prospective trial will test primary safety and effectiveness and plans to enroll up to 145 patients across as many as 30 sites, including three outside the United States (ClinicalTrials.gov NCT07018596).
The nPulse system uses nanosecond pulsed-field ablation (nsPFA), which delivers much shorter, lower-energy pulses than existing systems. It is designed to create a full circumferential pulmonary vein lesion in one brief application, reducing the need to reposition the catheter or stack lesions. Investigators say this approach may reduce collateral injury, simplify workflow in the EP lab, and improve durable freedom from atrial arrhythmias; a related European feasibility study has enrolled 150 patients so far.
Read Announcement- Drug:
- nPulse™ Cardiac Surgical System
- Announced Date:
- December 9, 2025
- Indication:
- treatment of atrial fibrillation (AF)
Announcement
Pulse Biosciences, Inc. announced a research collaboration with The University of Texas MD Anderson Cancer Center to examine the use of the Company's nPulse™ Vybrance™ Percutaneous Electrode System for treatment of thyroid cancers.
AI Summary
Pulse Biosciences announced a research collaboration with The University of Texas MD Anderson Cancer Center to study its nPulse Vybrance Percutaneous Electrode System for treating thyroid cancers. MD Anderson investigators led by Victoria Banuchi, M.D., will run a first-in-human clinical feasibility study targeting papillary thyroid microcarcinoma. The trial is planned to start in early 2026 at two sites and enroll about 30 subjects. Under a material transfer agreement, preclinical work is also underway to test the technology against anaplastic thyroid carcinoma, a rare but highly deadly form with a five-year survival under 5%.
The nPulse Vybrance system uses nanosecond pulsed field ablation (nsPFA) energy delivered through a percutaneous needle electrode and console to remove cellular tissue nonthermally while sparing noncellular structures. Pulse Biosciences says this nonthermal approach may limit scarring and damage to nearby nerves and vessels, and the company is exploring other uses such as atrial fibrillation and surgical soft tissue ablation.
Read Announcement- Drug:
- nPulse™ Cardiac Surgical System
- Announced Date:
- October 24, 2025
- Indication:
- treatment of atrial fibrillation (AF)
Announcement
Pulse Biosciences, Inc announced the enrollment of the first patient in its NANOCLAMP AF Study for the treatment of atrial fibrillation (AF).
AI Summary
Pulse Biosciences announced the enrollment of the first patient in its NANOCLAMP AF Study, using the nPulse Cardiac Surgical System to treat atrial fibrillation during another heart surgery. The first procedure took place at St. Helena Hospital in California and used nanosecond pulsed field ablation to create precise, full-thickness lesions.
The NANOCLAMP AF trial is a single-arm, prospective, multicenter study set to prove the safety and effectiveness of this new clamp device. Several centers in the U.S. and overseas will join to enroll patients. Surgeons reported the tool was easy to handle and worked faster than expected, while aiming to protect healthy tissue.
By using a nonthermal energy source, the system may offer safer and quicker procedures compared to heat-based methods. If successful, NANOCLAMP AF could improve outcomes for people with atrial fibrillation and allow more patients to access effective surgical care.
Read Announcement- Drug:
- nPulse™ Cardiac Surgical System
- Announced Date:
- October 10, 2025
- Indication:
- treatment of atrial fibrillation (AF)
Announcement
Pulse Biosciences, Inc. announced late-breaking clinical study results from the nPulse™ Cardiac Surgical System first-in-human feasibility study at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark.
AI Summary
Pulse Biosciences announced late-breaking results from its first-in-human feasibility study of the nPulse™ Cardiac Surgical System at the 39th European Association for Cardio-Thoracic Surgery meeting in Copenhagen. This study evaluated safety and efficacy in 44 atrial fibrillation patients across Dutch centers. In a cohort of 24 patients assessed by electroanatomical mapping three months after ablation, the system achieved durable pulmonary vein isolation (PVI) in 94% of veins and 100% posterior box isolation. Average total ablation time was 50 seconds with 13 applications.
No esophageal or phrenic nerve injuries were reported, and there were no procedure-related severe or major adverse events. A live case recording showcased the device’s rapid workflow and consistent results. Pulse Biosciences plans to launch an IDE study this year to further validate the nonthermal nanosecond pulsed field ablation technology and aims for future commercial approval and broader patient access.
Read Announcement- Drug:
- nPulse™ Cardiac Surgical System
- Announced Date:
- October 7, 2025
- Indication:
- treatment of atrial fibrillation (AF)
Announcement
Pulse Biosciences, Inc. announced the upcoming presentation of early clinical data on the treatment of atrial fibrillation (AF) using the nPulse™ Cardiac Surgical System at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting from October 8-11th in Copenhagen, Denmark.
AI Summary
Pulse Biosciences, Inc. announced that it will present early clinical data on treating atrial fibrillation (AF) with its nPulse™ Cardiac Surgical System at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting, held October 8–11 in Copenhagen. The data highlight the safety and effectiveness of the company’s nanosecond Pulsed Field Ablation™ (nsPFA™) technology for AF treatment.
Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences, said the company is excited to feature this first clinical evidence at the world’s largest cardiothoracic surgery conference. He praised the dedication of clinicians who continue to evaluate and use the nPulse™ platform.
Key sessions include an October 8 “Pulsed Field Ablation (Live in a box 3D)” presentation at 10:40 am in Hall A1, Bella Center, and an October 10 e-poster on the first-in-human nsPFA™ study for surgical left atrial box isolation at 12:30 pm, Station 2.
The nPulse™ system delivers nanosecond pulses of electrical energy to non-thermally clear cardiac cells while sparing surrounding tissue. Pulse Biosciences is advancing this technology for AF and other surgical soft tissue applications.
Read Announcement
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
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