More to come soon!
$Pulse Biosciences(PLSE.US$ On November 27, 2023, Pulse Biosciences, Inc. (the “Company”) provided the following programmatic updates with respect to its proprietary CellFX nsPFA cardiac catheter and cardiac clamp: CellFX nsPFA Cardiac Catheter ● As of today, the Company has received all regulatory approvals and it has substantially completed all required activities to commence its planned catheter ablation feasibility study. The first study procedures in this clinical trial are scheduled for mid-December 2023. ● The Company expects to provide updates from these first procedures by the end of January 2024. CellFX nsPFA Cardiac Clamp ● The Company anticipate filing a 510(k) submission with the U.S. Food and Drug Administration (the “FDA”) for its cardiac surgery ablation clamp by the end of January 2024, and possibly by the end of December 2023. ● Pursuant to Section 510(k), once the application has been accepted, the FDA will conduct its substantive review and may request additional information from the Company based on that review. FDA guidance suggests the goal is to complete the 510(k) review within 90 calendar days, not including time required by the Company to respond to additional information requests. The time required to respond to any such requests will depend on the nature of the request.![]()
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