(RTTNews) - Pulse Biosciences (PLSE) said it has received the Breakthrough Device Designation from the FDA for the company's Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation. The company plans to pursue the premarket approval application pathway for FDA approval to market as opposed to the 510(k) route, and once FDA PMA approved, commercialize the nsPFA Cardiac Surgical System in the United States as a treatment for atrial fibrillation.
CEO Burke Barrett said: "We look forward to aligning with the FDA on a pivotal clinical trial design in the near-term and towards initiating our planned first-in-human cases in the Netherlands soon."
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