Shanghai Shineyo Medical’s Cardiac PFA System Gains NMPA Approval, Expanding Atrial Fibrillation Treatment Options in China

On February 26, 2025, the SHINERHYTHM™ cardiac pulsed field ablation system and RHYTHPULSE™ single-use cardiac pulsed field ablation catheter developed by Shanghai Shineyo Medical Instrument Co., Ltd. were officially approved for market launch by the National Medical Products Administration (NMPA) of China.

This product is one of several other domestically developed PFA devices to receive approval. It is indicated for the interventional treatment of arrhythmias such as atrial fibrillation. By utilizing non-thermal pulsed field technology, it precisely ablates myocardial cells while avoiding damage to surrounding tissues caused by traditional ablation methods, providing alternative for atrial fibrillation in clinical practice according to Shineyo Medical.

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