NMPA Approves Two Novel Pulsed Field Ablation Devices

On August 5, 2026, China's National Medical Products Administration announced the approval of two innovative cardiovascular devices from Shenzhen Bioheart Medical Technology Co., Ltd. :

Cardiac Pulsed Field Ablation (PFA) Generator – consists of the ablation console, power cord, grounding wire, and foot switch.

Single-Use Cardiac Pulsed Field Ablation Catheter – comprises the catheter and connecting cable; the catheter itself includes electrode assembly, shaft, handle, tail wire, loader, and side-arm three-way valve.

Used together, the system treats drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

How it works: The device delivers high-voltage, bi-directional, alternating nanosecond‑pulsed electric fields to induce irreversible electroporation in targeted myocardial tissue, leading to cell apoptosis and necrosis. This approach reduces tissue damage and improves procedural efficiency compared to conventional thermal ablation.

The NMPA has stated it will strengthen post-market surveillance to ensure patient safety.