NMPA Approves Domestic Intracardiac Echocardiography (ICE) System, Advancing Precision Cardiac Intervention

On April 30, 2026, the Intracardiac Echocardiography (ICE) System and Disposable ICE Catheter—developed by Xi’an Huafeng Medical Technology Co., Ltd.—officially received market approval from the NMPA.

Product Composition and Scope of Application

The system comprises two core components working in tandem: the ICE Diagnostic Equipment (consisting of the main console, monitor, and catheter connection unit) and the Disposable ICE Catheter (consisting of the catheter body, control handle, and connector).

Designed for integrated use, the system delivers advanced ultrasound imaging of the adult heart, great vessels, and internal cardiac anatomy. By providing clear visualization of intracardiac tissue structures, the device significantly facilitates transseptal punctures and other intricate endovascular procedures.

Key Technical Innovations

• Integrated Fluid Infusion: The catheter features an internal fluid lumen paired with distal exit ports, allowing clinicians to perform ultrasound imaging while simultaneously administering fluids (such as echo contrast agents or saline). This dual functionality reduces the frequency of instrument exchanges mid-procedure and streamlines the surgical workflow.
• Unified Puncture and Imaging: A transseptal puncture needle is seamlessly integrated directly into the ICE catheter, enabling imaging and puncture capabilities in a single step. Furthermore, the steerable tip features an adjustable deflection length to accommodate diverse anatomical variations, substantially increasing procedural flexibility.
• High-Resolution Imaging with Real-Time Feedback: The micro-ultrasound probe is delivered into the cardiac chambers via the femoral vein to provide high-resolution, 2D real-time imaging. This serves as a precise navigation tool for arrhythmia ablation, structural heart interventions, and other complex procedures. Collectively, these innovations elevate patient safety, flatten the learning curve for operators, and equip cardiac interventionists with a highly dependable clinical tool.