Broncus Holding Corporation has secured the European Union Medical Device Regulation (EU MDR) CE marking for its BroncTru® Disposable Transbronchial Puncture Dilation Catheter. The certification confirms compliance with the latest EU regulatory standards, enabling market entry across Europe and other CE-recognising jurisdictions.

BroncTru® integrates multiple patented technologies to access peripheral pulmonary nodules unreachable by conventional bronchoscopes. Guided by a navigation system, the device performs puncture, dilation and tunnel creation, establishing a direct channel for endoscopic instruments to diagnose and treat lung lesions. Approved clinical applications range from endobronchial ultrasound-guided cryobiopsy and transbronchial lung biopsy to targeted drug delivery, ablation procedures and lesion localisation.

With the EU MDR CE mark, BroncTru® now holds regulatory clearance from the National Medical Products Administration of China, the U.S. Food and Drug Administration and health authorities in Taiwan (China), Indonesia, Thailand and Malaysia. The expanded portfolio strengthens Broncus’s international commercial positioning and supports further penetration into global markets.