Domestic Brain-Computer Interface 'Beinao-1' Advances Toward Nationwide Rollout in 2027 Following IND Submission

Source: Medtech Dive

Recently, China has made significant progress in the clinical application of brain-computer interfaces.

According to the speech delivered by Zhao Jizong, an academician of the Chinese Academy of Sciences, at the interdisciplinary postdoctoral academic exchange event on “Clinical Brain-Computer Interfaces,”"Beijing Brain No. 1" Intelligent Brain-Computer Interface SystemCurrently completed10 casesHuman implantation: Registration clinical trial officially launched, with enrollment and surgical implantation completed for 3 patients.

As planned,Enrollment of all 40 cases will be completed in 2026., advance the clinical validation of "Beinao No. 2" in the second half of the year.In 2027, "BeiNao No. 1" will launch pilot promotion in qualified Grade A tertiary hospitals across China.

Compared with the world's first fully implantable 128-channelThe multi-center clinical trial of BCI (the LEAP study, launched on May 18 at Beijing Tiantan Hospital) constitutes the "dual engines" of Beijing's BCI clinical translation—the BeiNao series independently advancing registration clinical trials, while the multi-center trial at Tiantan Hospital proceeds in parallel, jointly validating from different technical routes.Invasive BCIthe potential to transition into serious medical care."

The project is advancing at a remarkably rapid pace, referencing the world’s first approved invasive brain-computer interface—Timeline from approval application to market authorization for Neuracle’s implantable brain-computer interface hand motor function compensation system: October 2023,NEOThe product completed its first implantation at Xuanwu Hospital of Capital Medical University; in August 2024, the product entered the National Medical Products Administration.Innovative Healthcare(Rights Protection)Special Review Channel for Medical Devices; Since May 2025, multi-center registration clinical trials have been launched at 11 hospitals across China, setting an industry record by completing 32 clinical trial cases within 78 days.2025Year11Complete clinical endpoint data collection by the end of the month.；2026Year3Month13was officially approved on that day.

“North Brain One” Poised to Compete for the World’s Second Invasive Brain-Computer Interface Approval!