Pulse Biosciences announced on September 8, 2025, that the U.S. Food and Drug Administration (FDA) granted approval for the company’s Investigational Device Exemption (IDE). This approval allows Pulse Biosciences to initiate its nsPFA Cardiac Surgery System Study, named NANOCLAMP AF, for the treatment of atrial fibrillation.
This regulatory milestone is significant as it marks the first advancement of pulsed field ablation technology into the cardiac surgical field. The NANOCLAMP AF study will be a pivotal clinical trial, crucial for gathering the necessary data to support future FDA marketing authorization.
The IDE approval is a critical step in validating the nsPFA Cardiac Surgery System's potential to improve patient outcomes in atrial fibrillation. This development positions Pulse Biosciences to further demonstrate the safety and effectiveness of its proprietary technology in a large and underserved market.
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