The National Medical Products Administration (NMPA) has officially approved the market release of the ETcath Interventional Surgery Assistance System, developed by Beijing-based medical technology company Weimai Medical.
This milestone marks the birth of the world’s first interventional surgery robot integrating “eye-hand-brain” coordination, signifying China’s historic leap from a follower to a leader in the high-end medical equipment sector.
With this approval, ETcath becomes the first Class III domestically developed interventional surgery robot to enter and successfully pass the NMPA’s Special Review Procedure for Innovative Medical Devices.
ETcath is also the first interventional surgery robot in China to undergo a prospective randomized controlled clinical trial (RCT). The trials were conducted at five top-tier hospitals, including Beijing Anzhen Hospital, affiliated with Capital Medical University.
Having undergone hundreds of clinical trials, ETcath has achieved a 100% success rate in coronary intervention procedures, setting a new benchmark in the field of robotic-assisted surgery in China.
