Friday, September 18, 2026
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Tag: CorTec

3 articles

Policy & Regulation

Germany's data protection commissioner presses Europe for tighter rules on bidirectional brain-computer interfaces

Prof. Dr. Louisa Specht-Riemenschneider, the outgoing German Federal Data Protection and Freedom of Information Commissioner (BfDI), used a BCI-themed academic conference at the University of Bonn on 4 September 2026 to press for tighter European handling of neural data. Her formal underpinning is a Berlin Group Working Paper on Emerging Neurotechnologies published on 15 May 2025 through BfDI, which invokes GDPR Article 9 (health and biometric data) and the EU AI Act (Article 5 subliminal-manipulation ban, Annex III high-risk classification for medical BCI) as existing legal ground. The intervention lands one month before Specht-Riemenschneider steps down for health reasons on 30 September 2026. Her Bundestag-elected successor Prof. Dr. Moritz Hennemann of Freiburg takes office on 1 October 2026, and his own position on neurodata is not publicly disclosed.

Sep 6

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

Market Moves

The BCI category is broadening beyond motor restoration in 2026

Across the first half of 2026 and the first weeks of the second half, three US Food and Drug Administration Breakthrough Device Designations were granted to non-motor-indication BCI and neuromodulation devices, Cortigent's existing Breakthrough-designated visual cortical prosthesis programme disclosed a secondary stroke motor rehab arm, three first-in-human or investigational-device clinical milestones landed, and two significant peer-reviewed publications extended the field's clinical use case. The motor-restoration pipeline itself continued to expand in the same window. This is a synthesis piece on what the data pattern actually shows and does not show.

Jul 13