XuanYu Medical's Cardiac Pulsed Field Ablation System Included in Pudong New Area's Innovative Medical Products Directory

May 29, 2025 14:03 CST Updated 14:03

ShineyoMedical

Provider of Atrial Fibrillation Electrophysiology and Peripheral Vascular Intervention Solutions

Recently,Shanghai Pudong New Area Health Commission,Shanghai Pudong New Area Science and Technology and Economy Committee,Shanghai Pudong New Area Finance Bureau,Shanghai Pudong New Area Medical Security Bureau,Shanghai Pudong New Area Market Supervision and Administration BureauHe FaPublishedPudong New Area Innovative Pharmaceutical and Medical Device Product Recommendation Catalog (First Batch of 2025), ShineyoMedical's Cardiac Pulsed Field Ablation System and Disposable Cardiac Pulsed Field Ablation Catheter are listed.。

According to the "High-Quality Development Action Plan for the Biomedical Industry in Pudong New Area (2022-2024)" (Document No. [2022] 2 of the Pudong Government Office) and the "Pudong New Area's Measures to Strengthen...In accordance with the spirit of documents such as the "Implementation Opinions on Promoting the High-Quality Development of the Biomedical Industry through the Integration of Medicine" (Puwei [2023] No. 17), Pudong New Area conducts an annual review of innovative pharmaceuticals and medical devices, selecting a list of products with high innovation and significant clinical demand for recommendation. This initiative aims to...Deep Integration of Medicine and Industry, Support Clinical Application of Innovative Drugs and Devices, Stimulate...Innovative Drive of Biopharmaceutical Enterprises. The recommendation of ShineyoMedical's Pulsed Electric Field Ablation System in the catalog represents high recognition of the product's innovation.

ShineyoMedical was founded in May 2020, focusing on the fields of electrophysiology and peripheral vascular intervention. It has now built R&D centers and Class 10,000 clean workshops that meet the GMP production standards for Class III medical devices, with a total area of over 5,000 square meters in Shanghai and Suzhou. The company has obtained nearly a hundred patents cumulatively. ShineyoMedical has successively been awarded the qualifications of a National High-tech Enterprise and a Shanghai Specialized, Fine, Distinctive, and Innovative Small and Medium-sized Enterprise, and it undertakes the biopharmaceutical project of the Pudong New Area Science and Technology Development Fund Industry-Academia-Research Special Program.

ShineyoMedical's self-developed multi-channel cardiac pulse field ablation system,It was officially approved for marketing by the NMPA on February 26 this year, becoming the first domestically produced PFA system approved in China that integrates multi-channel, large-lesion, and targeted ablation. The systemComposed of the ShineRhythm® Multi-Channel Cardiac Pulsed Field Ablation System and the RhythPulse® Single-Use Cardiac Pulsed Field Ablation Catheter. Mainly used for the treatment of rapid arrhythmias, it achieves irreversible electroporation of myocardial cells in the target area by precisely delivering high-voltage pulses to myocardial tissue, permanently isolating abnormal electrical signal conduction and restoring normal sinus rhythm to achieve therapeutic purposes.