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Pulse Biosciences’ Cardiac Surgery System Receives FDA Breakthrough Device Designation

The Pulse Biosciences CellFX® Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System has been granted FDA Breakthrough Device Designation, recognizing its potential in treating atrial fibrillation (AF) using a non-thermal ablation approach. Unlike traditional thermal ablation methods, which rely on extreme heat or cold, this system applies nanosecond-duration, high-amplitude electrical pulses to create precise lesions…

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