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Pulmonary Denervation System Gets Breakthrough Device Designation From FDA
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3 Articles
Gradient’s Pulmonary Artery Denervation System Receives FDA Breakthrough Designation - Endovascular Today
May 19, 2025—Gradient Denervation Technologies, which is based in Paris, France, announced that the company’s pulmonary artery denervation (PADN) system has received FDA Breakthrough Device designation. The designation allows for an expedited review pathway for devices that have the potential to provide more effective treatment for life-threatening or debilitating conditions and meet FDA’s rigorous standards for safety and efficacy, noted the co…
Gradient’s Pulmonary Artery Denervation System Receives FDA Breakthrough Designation - Cardiac Interventions Today
May 19, 2025—Gradient Denervation Technologies, which is based in Paris, France, announced that the company’s pulmonary artery denervation (PADN) system has received FDA Breakthrough Device designation. The designation allows for an expedited review pathway for devices that have the potential to provide more effective treatment for life-threatening or debilitating conditions and meet FDA’s rigorous standards for safety and efficacy, noted the co…
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