Bairen Medical: Radiofrequency Ablation System Enters Special Review Process for Innovative Medical Devices

Bairen Medical announced that the radiofrequency ablation system independently developed by the company has been approved by the Medical Device Technology Evaluation Center of the National Medical Products Administration to enter the special review process for innovative medical devices. The radiofrequency ablation system consists of three products: an ablation instrument, ablation forceps, and ablation pen, and is specifically used for the surgical treatment of persistent and permanent atrial fibrillation in cardiac surgery. This product utilizes surgical ablation under direct vision and has significant clinical advantages, potentially improving the postoperative quality of life for patients. Entering the special review process for innovative medical devices will help shorten the product registration period, but the registration and approval from the National Medical Products Administration are still required for market entry.