Shanghai Microport EP Medtech Secures NMPA Fast-Track Designation for EasyEcho Catheter

Shanghai Microport EP Medtech Secures NMPA Fast-Track Designation for EasyEcho Catheter

China’s Shanghai Microport EP Medtech Co., Ltd (SHA: 688351) has announced that it has received fast-track designation from the National Medical Products Administration (NMPA) for its disposable intracardiac ultrasound imaging catheter, EasyEcho. This designation accelerates the regulatory review process, bringing the innovative device closer to market approval.

Product Innovation and Clinical Benefits
The EasyEcho intracardiac ultrasound catheter integrates three-dimensional ultrasound positioning technology, enabling high-definition imaging of intracardiac structures and medical instruments. When used in conjunction with ultrasound imaging equipment and the Columbus three-dimensional cardiac electrophysiological mapping system, it provides precise visualization during cardiac interventions. This advanced imaging capability helps operators accurately assess treatment effects and enhance surgical safety, setting a new standard for precision in cardiac procedures.

Clinical Trial Progress
Currently, the EasyEcho catheter is undergoing pre-market clinical trials, a critical step toward securing full marketing approval in China. The trials are designed to validate the device’s safety and efficacy, supporting its potential to transform the landscape of cardiac interventions by offering real-time, high-definition guidance.-Fineline Info & Tech