Pulse Biosciences receives FDA's Breakthrough Device Designation for its Cardiac Surgery System using pulsed field ablation technology to treat atrial fibrillation.
Pulse Biosciences (PLSE) received the Breakthrough Device Designation from the FDA for its Cardiac Surgery System, which uses the company's pulsed field ablation technology. The system aims to treat atrial fibrillation by ablating cardiac tissue. PLSE plans to pursue the premarket approval application pathway for FDA approval and commercialization in the US once approved.
July 08, 2024
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