Broncus Holding (02216.HK): BroncTru® Catheter Secures EU MDR CE Certification, Strengthening Global Product Layout

NewTimeSpace News: Broncus Holding Corporation (stock code: 2216) announced that its self-developed BroncTru® disposable bronchoscopic dilation catheter has obtained CE certification under the EU Medical Device Regulation (EU MDR). The company stated that this marks an important step forward in its international registration and global product layout.

According to the announcement, BroncTru® holds multiple patented technologies. Under navigation system guidance, it enables precise access to peripheral pulmonary nodules that are difficult to reach with conventional bronchoscopes. By puncturing, dilating, and establishing a tunnel, it creates a direct working channel for other endoscopic tools to reach target lesions in the lungs, serving as the core tool for Bronchoscopic Transparenchymal Nodule Access (BTPNA). The product can be used in combination with diagnostic and therapeutic products to rapidly achieve diagnosis and treatment of lesions throughout the lungs. Its application scenarios include, but are not limited to, various transbronchial biopsy sampling procedures, targeted drug delivery via bronchoscopic dilation catheter, transbronchial ablation, and transbronchial assisted positioning.

The announcement noted that EU CE certification is a mandatory qualification for medical devices entering the European market. As of the date of this announcement, BroncTru® has received registration approvals from China's NMPA, the U.S. FDA, and the EU MDR CE, and has been approved for launch in the Taiwan region of China, Indonesia, Thailand, and Malaysia.

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