Beijing Balance Medical's ablation system enters fast-track review

Beijing Balance Medical Technology Co., Ltd. has announced its self-developed radiofrequency ablation system has been accepted into the special review procedure for innovative medical devices by the National Medical Products Administration's Medical Device Technical Review Center. The "Radiofrequency Ablation System" is a Class III medical device.

The system includes an ablation unit, ablation forceps, and an ablation pen, designed for the surgical treatment of persistent and permanent atrial fibrillation (AFib). It aims to create trans-mural, continuous, and irreversible linear lesions on the atrial tissue to eliminate AFib triggers and restore sinus rhythm.

While this special review is expected to shorten the registration period, the product still requires a formal registration application and approval from the National Medical Products Administration for production and market launch. The company states that entering this innovative review program will not significantly impact its recent performance, but ultimate market approval remains uncertain.