Suzhou-Based Ablation System Developer AccuPulse Medical Receives NMPA Approval for Innovative PFA Cardiac Ablation System

May 08, 2025 18:05 CST Updated 18:05

AccuPulse

Developer of products in the field of cardiac electrophysiology

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Recently, the third-class innovative medical device independently developed by AccuPulse Medical Technology Co., Ltd. —— Cardiac Pulse Field Ablation Instrument and Disposable Use HeartAccuPulse Medical Technology Co.Ltd's disposable cardiac pulsed field ablation catheter has been officially approved for marketing by the National Medical Products Administration. Among these, the disposable cardiac pulsed field ablation catheter`, Conquer`PFA AblationThe challenge of catheter stability and anatomical adaptability brings a new solution for pulmonary vein isolation (PVI).

Yuansheng Venture CapitalParticipated in AccuPulse's Pre-A and A rounds of financing in December 2021 and June 2022, respectively.

The newly approved AccuPulse® Single-Use Cardiac Pulsed Field Ablation Catheter and AccuBlator® Multi-Channel Pulsed Field Ablation Generator together form the PFA Cardiac Pulsed Field Ablation System. This system is compatible with most commercially available 3D mapping systems currently on the market, significantly shortening the learning curve. Its unique bipolar biphasic pulse energy design enables rapid microsecond pulse delivery, greatly improving surgical efficiency. Meanwhile, the optimized energy formulation allows the majority of patients to undergo treatment under local anesthesia. Validated by eight authoritative PFA Cardiac Pulsed Field Ablation System research centers across China and 17 electrophysiology experts, this system demonstrates excellent intraoperative performance, offering patients with tachyarrhythmia a safer, more efficient, and convenient treatment option.

In the process of advancing the entire workflow from product development to market launch, the Suzhou Inspection Branch and the Suzhou Sub-center for Evaluation and Verification have worked in synergy to establish an industry support system that covers the entire life cycle of medical devices. Guided by the policy orientation of "supporting the innovative development of high-end medical devices," an innovative dynamic management mechanism for the "List of Innovative and Major Projects" has been established. Through regular screening and selection, medical device projects with technological innovation are included in the list, updated in real time according to project progress, and precisely guided. Dedicated personnel are assigned to provide end-to-end closed-loop services from product development, system verification to registration application, formulating differentiated service strategies for different stages. At the same time, a rapid response mechanism is established to timely collect and coordinate solutions to difficulties and bottlenecks encountered by enterprises during the application process, extending service reach to every key node up to product market entry. Additionally, by building a "government-enterprise direct communication" platform, regular technical seminars and "face-to-face" application guidance sessions are conducted, and expert teams are organized to assist enterprises in addressing compliance key points during the registration application process, ensuring compliance with relevant medical device regulations and helping enterprises efficiently complete the registration application.

Next, the Suzhou Inspection Branch and the Suzhou Sub-center of the Evaluation and Verification Center will continue to deepen the innovation of industrial service mechanisms, focusing on the high-quality development goals of the biopharmaceutical industry, and steadily promote the implementation of the "Suzhou Medical Device Innovation and Major Projects List" system. At the same time, they will accelerate the construction of a smart regulatory system, continuously improve regulatory measures, and promote the dual enhancement of service levels and regulatory efficiency, providing a solid guarantee for Suzhou to become a highland of the biopharmaceutical industry.

About AccuPulse

AccuPulse Medical Technology Co., Ltd. was founded in November 2020. As a startup focusing on the cardiac electrophysiology sector, AccuPulse leverages its core team’s extensive experience in the research, development, registration, and commercialization of cardiac electrophysiology medical devices to provide patients with a one-stop treatment solution for atrial fibrillation.

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About YuanSheng Ventures

Yuansheng VenturesIs an investment institution focused on early and growth-stage healthcare, headquartered at Suzhou BioBAY with a global reach. It has already invested in over 200 outstanding companies in the life sciences sector, covering four major areas: novel drug development, medical devices, in vitro diagnostics and precision medicine, as well as future medical technologies, achieving substantial investment returns. Among these, 19 companies have gone public on capital markets such as the Hong Kong Stock Exchange and the STAR Market. OrbiMed China has been repeatedly ranked among the top 10 venture capital funds in China's healthcare sector and recognized as one of the most active healthcare investors in China. With a team of seasoned professional investors and a world-class scientific advisory board, OrbiMed China possesses extensive experience in entrepreneurship, venture capital, and corporate operations within the biopharmaceutical industry. Leveraging professionalism, dedication, and abundant industry resources, we are committed to becoming one of the most successful healthcare and pharmaceutical venture capital funds in China.