Pulse Biosciences Announces FDA IDE Approval to Initiate its nPulse Cardiac Catheter Ablation System Study for the Treatment of Atrial Fibrillation
Pulse Biosciences, Inc (PLSE)
Last pulse biosciences, inc earnings: 11/7 03:42 pm
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Source: Business Wire
HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today 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).This single-arm, multicenter, prospective study is designed to demonstrate primary safety and effectiveness of the nsPFA Cardiac Catheter System for the treatment of recurrent drug-resistant symptomatic paroxysmal AF. Up to 30 sites, including three sites outside the United States, are planned to enroll up to 145 patients. Additional details of the study are available on clinicaltrials.gov (NCT07018596).“Pulsed field ablation has already reshaped h
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News
- Pulse Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
- PLSE Wins FDA IDE Approval to Launch nPulse AF Ablation Study Trial [Yahoo! Finance]Yahoo! Finance
- Pulse Biosciences Announces FDA IDE Approval to Initiate its nPulse Cardiac Catheter Ablation System Study for the Treatment of Atrial Fibrillation [Yahoo! Finance]Yahoo! Finance
- Pulse Biosciences, Inc. Announces Initiation of Research Collaboration for the Treatment of Benign and Malignant Thyroid Tumors with nPulse™ TechnologyBusiness Wire
- Pulse Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
PLSE
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- 11/5/25 - Beat
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- 12/18/25 - Form 8-K
- 12/12/25 - Form 8-K
- 12/9/25 - Form 8-K
- PLSE's page on the SEC website