Pulse Biosciences Files 510(k) Submission with U.S. FDA for its CellFX nsPFA Percutaneous Electrode
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 primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel CellFX nsPFA percutaneous electrode.The Company’s percutaneous electrode is an image-guided needle designed to harness CellFX nsPFA energy to deliver precise and complete nonthermal ablation of cellular tissue without damage to noncellular structures. The percutaneous electrode is designed for non-cardiac applications.“We are very happy to make this announcement earlier than expected in part due to the efficiency of the FDA’s new electronic submission platform,” said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. “We look forward to collaborating with the FDA throughout the review process.”Pursu
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News
- Pulse Biosciences (PLSE): Valuation Check After FDA IDE Approval for nPulse Cardiac Ablation Trial [Yahoo! Finance]Yahoo! Finance
- 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 Announces FDA IDE Approval to Initiate its nPulse Cardiac Catheter Ablation System Study for the Treatment of Atrial FibrillationBusiness Wire
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