Tag: Horizontal-Regulator-posture

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

ABILITY Neurotech reaches first-in-human at TUM Munich

On Tuesday 21 July 2026, Geneva-based ABILITY Neurotech announced the first-in-human recording of its fully implantable, batteryless brain-computer interface at TUM University Hospital Rechts der Isar in Munich. The device is a 128-channel sub-scalp ECoG array with a laser-based transcutaneous optical data link streaming raw neural signals through the scalp at 50 megabits per second. The first cohort is up to five brain-tumour surgery patients recording 20 to 30 minutes of intraoperative data each. The company's separate chronic implantation trial in ALS patients at UMC Utrecht, cleared by Dutch regulators on 26 May 2026, has not yet performed a surgery.

Jul 24

Industry News

AMD patients are reading letters again as PRIMA lands its CE mark in Europe

On Wednesday 22 July 2026, Science Corporation announced the European commercial launch of PRIMA, a two-millimetre subretinal photovoltaic chip that restores functional central vision in patients blinded by geographic atrophy from age-related macular degeneration. The CE mark, granted by DEKRA under the EU Medical Device Regulation, covers 30 European countries. The first commercial implant is expected in Germany. PRIMA is the first CE-marked implant to restore, rather than merely slow, central vision loss in AMD, and the FDA has granted it Humanitarian Use Device designations on the same day. Max Hodak's five-year-old company inherited the technology from Pixium Vision after the French developer's 2024 collapse.

Jul 22