Beijing Zhiran's fully implanted wireless intracortical flexible BCI with over 100 channels, in a multicenter registration-style trial (LEAP) that launched at Tiantan Hospital in May 2026. Details come from Chinese hospital and state media releases and company statements.
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
Beijing Zhiran Medical’s system combines micrometre-thick flexible intracortical electrodes with a fully implanted wireless unit. The first implantation was in October 2025 in a glioma patient. A multicenter GCP trial for tetraplegia, LEAP, began on May 18, 2026. Figures here are company or hospital statements; no data are published.
Identity
Field
Value and source scope
Device
智冉医疗 ultra-100-channel invasive flexible BCI (超百通道侵入式柔性脑机接口系统): intracortical ultra-thin flexible electrodes and a fully implanted wireless signal acquisition unit, with a robot for electrode implantation. Trial name LEAP [1, 2, 3]
Manufacturer
北京智冉医疗科技有限公司 (Beijing Zhiran Medical Technology), founder and CEO Song Qi; trial sponsor [1, 2, 3]
Interface class
Intracortical flexible electrodes with a fully implanted wireless unit [1, 3]
Origin
Beijing Zhiran Medical, with Tiantan Hospital as lead clinical site [1]
First demonstrated
First clinical implantation reported October 24, 2025 at China-Japan Union Hospital of Jilin University in a 52-year-old glioma patient, with electrode placement error under 0.5 mm under robot guidance and intraoperative MRI (hospital statement via China News Service) [4]
First human implant
October 2025 at China-Japan Union Hospital of Jilin University, described as the first domestic ultra-100-channel invasive flexible BCI implantation [4]. That patient had a brain tumor in a functional area, not paralysis
Species studied
Human
Regulatory status
Multicenter GCP clinical trial (LEAP) launched May 18, 2026 at Tiantan Hospital, 11 institutions joined, first cohort of 32 patients planned [1, 2]. The company says its electrodes hold Chinese and US patents [3]. Not approved
Function
Records single-neuron action potentials at high throughput to decode movement intent for tetraplegia after spinal cord injury [1, 2]
Target tissue
Cerebral cortex, intracortical electrodes [1, 4]
Geometry and architecture
Field
Value and source scope
Interface type
Ultra-thin flexible intracortical electrodes, micrometre thickness, about one tenth of a hair in diameter, implanted with a robot [3, 4]
Array layout
Electrode count
128 channels in the first implantation [4]. Tiantan and Xinhua call the trial system ‘over 100 channels’ without a number [1, 2]. Zhiran’s CEO said a next-generation product of up to 1,000 channels has finished initial development (company statement) [3]
Pitch
Electrode lengths
Shank width and thickness
Tip and exposed site geometry
Contact coating
Insulation
Insertion method
Robot-guided, with intraoperative MRI to find functional cortex and error under 0.5 mm, in the first implantation [4]
Anchoring and fixation
Electrode and channel physics
Field
Value and source scope
Exposed site area
Electrode material
Impedance (with measurement frequency)
Noise floor or SNR
Recording modality
Sampling rate
Stimulation capability
Charge injection limit
Reference and ground
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Insertion trauma and BBB disruption
Vascular disruption risk
Micromotion sensitivity
Gliosis and encapsulation
Neuron loss near sites
Foreign-body response mitigation
Typical failure modes
System architecture
Field
Value and source scope
Onboard electronics
Fully implanted acquisition unit supporting 30 kHz high-throughput signal acquisition [3]
Data path
Wireless; Bluetooth transmission per the CEO [3]. A coin-sized wireless module placed under the scalp per China News Service [4]
Telemetry bandwidth
Sampling rate
30 kHz per the CEO’s description of the acquisition unit [3]
Power
Built-in rechargeable medical-grade battery with wireless charging, per Tiantan and Xinhua [1, 2, 3]
Thermal management
Packaging and hermeticity
MRI compatibility
Surgical complexity
Output connectors
Performance envelope
Field
Value and source scope
Acute yield
Chronic yield
Stability over time
Longevity
Revision and explant experience
Adverse events
Notable demonstrations
Hospital statement that first implantation recorded high-throughput single-neuron action potentials [4]. Tiantan states earlier trials showed good safety and effectiveness (no data) [2]
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
At least 1 in the October 2025 implantation; LEAP plans 32 in its first cohort [2, 4]
Preclinical cohort
Follow-up duration
Indications
Motor function improvement in tetraplegia from spinal cord injury, per Tiantan and Xinhua [1, 2]
Trials and registries
LEAP: prospective multicenter GCP trial, Tiantan Hospital as lead site, sponsored by Beijing Zhiran, 11 hospitals as of May 18, 2026 [1, 2]. No ClinicalTrials.gov or ChiCTR identifier was found for LEAP in this search
Primary outcomes
Key limitations
Company and hospital statements only, no results published. Hospital release for the first implant used a glioma patient. The count ‘over 100 channels’ is stated as 128 only in a news report of the first case
Engineering tradeoffs
Field
Value and source scope
Strengths
Single-neuron recording, wireless fully implanted design with rechargeable battery, robot-assisted placement, per the company [1, 3]
Limitations
Intracortical penetration; no chronic human data published [1]
Scaling constraints
Version boundary
The 128-channel configuration of the first implantation is the one specified here. A higher-channel generation of up to 1,000 channels is described by the company as early development and is not covered.