October 2026
Neuracle Lists K1014-15 Implantable EEG Electrode Kit in UDI Database
Neuracle Medical Technology (Shanghai) Co., Ltd. listed its K1014-15 Implantable EEG Electrode Kit in the National Medical Products Administration's medical device unique identification database. The entry describes a kit containing a cortical electrode (1014-15) and supporting components, forming part of an implantable BCI hand motor function compensation system. The complete system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The record identifies the kit and its relationship to the system; UDI listing itself is neither a new marketing authorization nor evidence of safety or improved hand function in patients.
Neuracle Lists Model 1014-15 Cortical Electrode in NMPA UDI Database
Neuracle Medical Technology (Shanghai) Co., Ltd. listed its Model 1014-15 cortical electrode in the National Medical Products Administration's medical device unique identification database. The entry identifies the electrode as a component of an implantable EEG electrode kit, which forms part of an implantable BCI hand motor function compensation system. The system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The record specifies the electrode's model, identifier, and relationship to the system; UDI listing itself is neither a new marketing authorization nor clinical evidence of improved hand function.
Neuracle Lists K1014-35 Implantable EEG Electrode Kit in UDI Database
Neuracle Medical Technology (Shanghai) Co., Ltd. listed its K1014-35 Implantable EEG Electrode Kit in the National Medical Products Administration's medical device unique identification database. The entry describes a kit containing a cortical electrode (1014-35) and supporting components, forming part of an implantable BCI hand motor function compensation system. The complete system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The record identifies the kit and its relationship to the system; UDI listing itself is neither a new marketing authorization nor evidence of safety or functional improvement in patients.
Neuracle Lists Model 1014-25 Cortical Electrode in NMPA UDI Database
Neuracle Medical Technology (Shanghai) Co., Ltd. listed its Model 1014-25 cortical electrode in the National Medical Products Administration's medical device unique identification database. The entry identifies the electrode as part of an implantable EEG electrode kit, which is a component of an implantable BCI hand motor function compensation system. The full system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The record identifies the electrode and its relationship to the kit and system; UDI listing itself is neither a new marketing authorization nor clinical evidence of improved hand function.
Neuracle Lists Implanted EEG Electrode Kit in NMPA UDI Database
Neuracle Medical Technology (Shanghai) Co., Ltd. listed an Implanted EEG Electrode Kit, Model K1014-25, in the National Medical Products Administration's medical device unique identification database. The entry describes a kit containing a cortical electrode (1014-25) and supporting components, forming part of an implanted BCI hand motor function compensation system. The system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The record identifies the kit and its relationship to the system; UDI listing itself is neither a new marketing authorization nor evidence of functional improvement in patients.
Neuracle Lists Cortical Electrode in NMPA UDI Database
Neuracle Medical Technology (Shanghai) Co., Ltd. listed its Model 1014-35 cortical electrode in the National Medical Products Administration's medical device unique identification database. The entry identifies the electrode as a component of an implanted EEG electrode kit, which in turn forms part of an implanted BCI hand motor function compensation system. The system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The entry clarifies these component relationships; UDI listing itself is neither a new marketing authorization nor evidence of clinical effectiveness.
Neuracle UDI Listings Cover Two BCI System Models and Two Electrode Kit Models
China’s NMPA UDI database lists Neuracle’s NEO-M and NEO-M Pro hand motor function compensation system models under registration certificate 国械注准20263120537, and K1014-25 and K1014-35 implantable EEG electrode kits under 国械注准20263120536. The descriptions identify the system’s implantable components, EEG transceiver, pneumatic glove and software.
September 2026
FDA Clears Ceribell EEG Analysis Software Under 510(k)
The US Food and Drug Administration has cleared EEG Analysis Software from Ceribell, a US medical device company, through the 510(k) pathway after finding it substantially equivalent to a device already on the market. The software performs quantitative analysis of EEG signals and is regulated as a Class II device under the Neurology review panel. A 510(k) clearance only requires showing equivalence to an existing product, a lower bar than the premarket approval required for high-risk devices. The FDA record does not describe the software's indications or specific analysis functions.
Neuracle Registers Cortical Electrode in China's NMPA Device Identifier Database
Neuracle Medical Technology (Shanghai) Co., Ltd. has registered a cortical electrode, model 1014-35, in the medical device unique identification (UDI) database of China's National Medical Products Administration (NMPA), under registration certificate Guoxiezhuzhun 20263120536. Neuracle's product line spans EEG acquisition equipment and implantable electrodes. The electrode belongs to an implantable EEG electrode kit (cortical electrode, blank electrode, electrode dilator, tunneler, torque wrench, lead fixation clip, fixation screws and electrode protective sleeve) that holds its own registration certificate and is also a component of an implantable BCI hand motor function compensation system. That system comprises a BCI implant, the electrode kit, an EEG signal transceiver, a pneumatic glove, a single-use surgical toolkit, and three software packages for EEG decoding, medical testing and clinical management.
FDA Clears Pascall Systems' EEG Software Under 510(k)
Pascall Systems, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pascall Sensor Unit (PSU1) on August 19, 2026, with the agency finding the device substantially equivalent. The device is a Class II medical device under regulation number 882.1400, classification name Non-Normalizing Quantitative Electroencephalograph Software.
August 2026
FDA Clears Precision Neuroscience's Layer 7 Cortical Interface for 30-Day Implantation
The FDA has cleared Precision Neuroscience's Layer 7 Cortical Interface to stay implanted for up to 30 days, up from a previous 510(k) limit of 30 minutes of intraoperative use. The longer window opens the door to extended clinical studies and marks an intermediate step toward a permanent implant.
July 2026
NeuroXess 'Sanquan' BCI Enters CMDE Innovative Medical Device Review Program
June 2026
FDA Approves Label Changes for Saluda Medical's Spinal Cord Stimulators
The FDA approved a premarket approval (PMA) supplement, S039, from Saluda Medical Pty, Ltd. on June 29, 2026, covering the CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA) and RECAP Viewer. The supplement is a labeling change touching indications, instructions for use, shelf life and trade name rather than an original approval of a new device; the products carry the generic name 'stimulator, spinal-cord, totally implanted for pain relief.' Saluda Medical is an Australian company whose Evoke system is one of the few closed-loop spinal cord stimulators on the market.
Neuracle Registers UDI for Implantable EEG Electrode Kit
Neuracle Medical Technology (Shanghai) Co., Ltd. registered an Implantable EEG Electrode Kit in the NMPA Medical Device Unique Identification database. The model is K1014-15, and the registration certificate number is 国械注准20263120536. The listed kit includes a cortical electrode, a blank electrode, and surgical and fixation components. It is both a product with its own registration certificate and a component of an implantable brain-computer interface hand motor function compensation system. The system also includes an implant, an EEG transceiver, a pneumatic glove device, and software. This entry identifies the product and its composition; it does not establish the complete system's registration status or clinical performance.
Neuracle Registers UDI for NEO-M Hand Motor Function Compensation System
Neuracle registered the NEO-M Implantable Brain-Computer Interface Hand Motor Function Compensation System in the NMPA Medical Device Unique Identification database. Its registration certificate number is 国械注准20263120537. According to the company's description, the system includes a BCI implant, an implantable EEG electrode kit, a disposable surgical tool kit, an EEG signal transceiver, a pneumatic glove device, and EEG decoding, medical testing, and clinical management software. All three software products have release version 1.0. The entry identifies the product and its components; UDI registration itself does not validate clinical efficacy or safety.
Neuracle Registers UDI for K1014-35 Implantable EEG Electrode Kit
Neuracle Medical Technology (Shanghai) Co., Ltd. registered the K1014-35 Implantable EEG Electrode Kit in the NMPA Medical Device Unique Identification database. Its registration certificate number is 国械注准20263120536. The company's description lists a cortical electrode, a blank electrode, and associated tools and fixation components. It describes the kit as both a product with its own registration certificate and a component of an implantable brain-computer interface hand motor function compensation system. The notes also list an EEG transceiver, a pneumatic glove device, and software within that system. The kit's UDI entry alone does not confirm the complete system's registration status or clinical performance.
Neuracle Registers UDI for K1014-25 Implantable EEG Electrode Kit
Neuracle Medical Technology (Shanghai) Co., Ltd. registered the K1014-25 Implantable EEG Electrode Kit in the NMPA Medical Device Unique Identification database. Its registration certificate number is 国械注准20263120536. According to the company's registered description, the kit includes a cortical electrode, a blank electrode, and associated tools and fixation components. It is both a product with its own registration certificate and a component of an implantable brain-computer interface hand motor function compensation system. The entry also lists the system's EEG transceiver, pneumatic glove device, and software. It identifies the kit and its relationship to the system; UDI registration itself does not validate clinical efficacy or safety.
Neuracle Registers UDI for NEO-M Pro Hand Motor Function Compensation System
Neuracle Medical Technology (Shanghai) Co., Ltd. registered the Implantable Brain-Computer Interface Hand Motor Function Compensation System in the NMPA Medical Device Unique Identification database. Its model is NEO-M Pro, and its registration certificate number is 国械注准20263120537. The description lists a BCI implant, an implantable EEG electrode kit, a disposable surgical tool kit, an EEG signal transceiver, a pneumatic glove device, and three software products, each with release version 1.0. The entry provides product identification and composition information; UDI registration itself should not be interpreted as validation of clinical efficacy or safety.
January 2026
BrainCo Registers FocusXin ADHD Hardware and Software as Class II Devices
BrainCo's FocusXin Medical Edition combines a single-channel prefrontal EEG device registered as 浙械注准20232071898 with ADHD rehabilitation software registered as 浙械注准20252211934. The Class II system is intended for supplementary rehabilitation training in children aged 6 to 12 with ADHD. Its defined medical use should not be generalized into approval for an unspecified consumer BCI product.
September 2025
Onward Medical ARC-EX system receives CE mark
ARC-EX is a non-invasive spinal cord stimulation device used to improve hand function in people with spinal cord injury; the CE mark allows commercial sale in the EU.
February 2023
BIS Convenes Conference on BCI Export Controls
The US Bureau of Industry and Security announced a two-day hybrid BCI conference with industry and academic experts, following its 2021 export-control inquiry.
November 2021
FDA Grants Breakthrough Status to Blackrock Neurotech's MoveAgain BCI
The FDA granted Breakthrough Device designation to Blackrock Neurotech's MoveAgain BCI System on November 16, 2021. The investigational system combines an implanted array, neural decoding and wireless output with the goal of allowing people with severe paralysis to control digital and assistive devices. The designation can expedite development and review but is not market approval.
October 2021
US Weighs Export Controls on BCI Technology
The US Bureau of Industry and Security published a 2021 advance notice seeking comments on export controls for BCI as an emerging technology, focused on national security.
May 2021
FDA Issues Final Guidance on Implanted BCIs
The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.