Tag: Mayo-Clinic

2 articles

Policy & Regulation

Four senior BCI neurosurgeon-scientists use Nature Neuroscience to press for tighter research ethics as implant numbers scale

Four clinician-scientists from Mayo Clinic, University College London, and Sichuan University published a Comment in Nature Neuroscience on 7 September 2026 setting out four ethical priorities for implantable brain-computer interface research: separating research participation from patient care, ensuring long-term support for study participants, avoiding disproportionate risks to participants for benefits realised mainly by others, and grounding research in meaningful clinical purpose. Lead author Kai J. Miller (Mayo Clinic) is the corresponding author. Senior author Gerwin Schalk (West China Hospital, Sichuan University) is the second corresponding author. Co-author Harith Akram (UCL Queen Square) declares a conflict of interest as Chief Investigator of Neuralink's GB-PRIME UK study. The Comment lands one day after Germany's outgoing federal data protection commissioner pressed Europe for tighter rules on bidirectional BCI, and ten months after UNESCO's General Conference adopted the first global standard on the ethics of neurotechnology in November 2025.

Sep 8

Industry News

CorTec wins a second FDA Breakthrough Device Designation for its Brain Interchange implant, this one for communication

German BCI operator CorTec GmbH announced on 31 August 2026 that FDA has granted a second Breakthrough Device Designation for its Brain Interchange implant, covering computer cursor control for people with non-progressive quadriplegia. The company's first Breakthrough Designation, in April 2026, covered stroke motor rehabilitation. Both designations apply to the same fully implantable, wireless, battery-free, bidirectional closed-loop platform with non-penetrating cortical surface electrodes. CorTec is now running two parallel FDA regulatory processes on identical hardware. The European regulatory route (EMA, CE Mark) is absent from the announcement.

Sep 1