On September 9, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) issued the Public Notice on Review Results of Applications under the Special Review Procedure for Innovative Medical Devices (No.15, 2026), proposing to approve eight medical device applications for entry into the special review procedure.
Among them, the "Implantable Wireless Brain-Computer Interface System" developed by Beijing Zhiran Medical Technology Co., Ltd. and the "Deep Brain Macro-Micro Electrode" from Beijing Huake Hengsheng Medical Technology Co., Ltd. were both selected, standing out as the biggest highlight in the BCI/neuromodulation field in this public notice.
The Special Review Procedure for Innovative Medical Devices is a "green channel" established by the state to encourage medical device innovation. Products admitted to this procedure will receive review support including early engagement, dedicated reviewers and scientific assessment, which is expected to accelerate their marketing approval process. The simultaneous selection of these two core BCI products marks that China’s invasive brain-computer interface and neuromodulation technologies are at a critical stage, moving from "laboratory validation" toward "regulatory recognition".
Beijing Zhiran Medical Technology Co., Ltd.
Build a world-leading next-generation flexible brain-computer interface platform
Zhiran Medical: Implantable Wireless Brain-Computer Interface System. Fully implantable and stretchable, it addresses the global challenge of "electrode detachment". The selected Implantable Wireless Brain-Computer Interface System is a clinical-grade high-throughput invasive flexible BCI system, consisting of two components: high-throughput flexible electrodes and a fully implantable wireless neural signal recorder.
Beijing Zhiran Medical Technology Co., Ltd., founded in 2022, is an innovative medical device enterprise focusing on the R&D of invasive flexible brain-computer interface technology. The company is committed to tackling ultra-thin flexible electrodes and precision diagnosis and treatment of neurological diseases. According to publicly disclosed data, its total financing has reached nearly RMB 600 million.
Angel Round: The company secured investment from institutions including Meta Capital in its early stage, while the specific amount remains undisclosed.
Series A (August 2025): The company secured over RMB 300 million in financing, co-led by the Social Security Fund Zhongguancun Independent Innovation Special Fund, Legend Capital and IDG Capital, with many well-known domestic and foreign institutions participating in the follow-on investment.
Series A+ (February 2026): The company raised another RMB 300 million in financing, led by CAS Star, with existing shareholders continuing to participate in the follow-on investment.
Channel Count: Surge from 128 to 1024 within one year
The channel count achieved a leap from 128 to 1024 within one year. In October 2025, Zhiran Medical completed China’s first clinical implantation of a multi-channel invasive flexible brain-computer interface with over 100 channels at China-Japan Union Hospital of Jilin University. The implanted 128-channel system successfully captured a large number of single-unit action potentials from the motor cortex. In less than half a year, the system’s channel count jumped to 1024 channels, supporting neuronal signal acquisition of up to 1024 channels. Paired with its self-developed deep neural network decoding algorithm, it enables millisecond-level real-time decoding. The entire workflow — from neural signal acquisition and decoding to driving external devices — takes less than 50 milliseconds, 3 to 5 times faster than human physiological response speed.
At the clinical level, LEAP Study — China’s first prospective, multicenter clinical trial of a multi-channel invasive flexible BCI system with over 100 channels, initiated by Zhiran Medical with the company serving as the lead research unit — was officially launched on May 18, 2026 at Beijing Tiantan Hospital, Capital Medical University. Adopting a fully implanted wireless design, the system integrates a medical-grade rechargeable battery and supports wireless charging, enabling patients to receive treatment and rehabilitation training in a more natural and comfortable environment.
Beijing Huake Hengsheng Medical Technology Co., Ltd.
The country’s first enterprise to commercialize consumables for intracranial EEG signal recording
Beijing Huake Hengsheng Medical Technology Co., Ltd., a wholly-owned subsidiary of Huake Precision (Beijing) Medical Equipment Co., Ltd., is a high-tech enterprise specializing in intracranial electrodes and brain-computer interfaces. The HKHS intracranial electrodes developed by Huake Hengsheng feature fully independent intellectual property rights and have been widely used in clinical practice for more than a decade.
Huake Hengsheng has been deeply engaged in the field of intracranial electrodes for nearly two decades. Its deep intracranial electrode is one of the few products of its kind in China to obtain dual certifications from China’s NMPA and the US FDA. With a diameter of only 0.8 mm, it can precisely record deep brain electrical signals in a minimally invasive manner, and realize epileptic focus localization and brain functional mapping via targeted electrical stimulation, delivering a revolutionary tool for the diagnosis and treatment of drug-resistant epilepsy. Featuring less trauma and better patient tolerance, it has effectively broken the import monopoly.
The deep brain macro-micro electrode admitted to the innovative medical device review program features a technical upgrade of "integrated macro-micro design" based on conventional deep electrodes. According to published patent information, Huake Hengsheng has continuously carried out technological iterations in the field of deep electrodes, covering multiple cutting-edge directions including macro-micro electrode manipulation devices, deep electrodes for synchronous biochemical and electroencephalographic monitoring (capable of simultaneous electrophysiological and biochemical monitoring), and ultrasound-synchronized electrodes (which can concurrently monitor brain temperature or intracranial pressure). Such technological underpinnings support the macro-micro electrode product to integrate single-cell-level signal acquisition and macroscopic field potential recording.
On the clinical front, Huake Hengsheng’s deep intracranial electrode products have entered the procurement systems of many Grade A tertiary hospitals, including The Second People’s Hospital of Shenzhen. Its deep intracranial thermocoagulation electrode (NMPA Registration No. 20233011148) has also been approved for marketing. It is indicated for epilepsy caused by hypothalamic hamartoma, epilepsy due to focal cortical dysplasia, and mesial temporal lobe epilepsy.
From "Green Channel" to Clinical Rollout: The Critical Leap in BCI Industrialization
Zhiran Medical’s implantable wireless brain-computer interface system and Huake Hengsheng’s deep brain macro-micro electrode represent key technologies advancing the clinical translation of invasive BCI from two respective dimensions: high-throughput signal acquisition and precise neuromodulation. The former focuses on motor function restoration and human-machine interaction, while the latter targets epileptic focus localization and neuromodulation. Together, they form a complete technological framework for BCI applications in the diagnosis and treatment of neurological disorders.
Admission to the Special Review Procedure for Innovative Medical Devices means that these two products have received preliminary recognition in terms of safety, effectiveness and clinical value, and will subsequently obtain expedited support during the review and approval process. From the "Green Channel" to clinical translation, the advancement timeline of these two products will provide important regulatory practice references for the large-scale application of China’s BCI industry.
The 2nd BCI Ecosystem Conference (iCCD2026) will be held in Shenzhen on October 28–29, 2026, bringing together clinicians, researchers, innovative enterprises and industrial capital from the brain-computer interface sector. As representative players in the invasive BCI track, Zhiran Medical and Huake Hengsheng have drawn the conference’s spotlight with their technological breakthroughs and clinical progress. Colleagues focused on BCI industrialization are welcome to gather in Shenzhen to witness this pivotal moment as China’s brain-computer interface moves from "technical verification" toward "clinical translation".
