Tag: bidirectional-BCI

2 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