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Terminal/Device DB/ABILITY Optical BCI
opticalnoneinvestigational

ABILITY Optical BCI

Implant Type
optical
Electrodes
0
Channels
0
FDA Status
none
Clinical Stage
First-in-human intraoperative signal acquisition at TU Munich (July 2026); no long-term implantation study conducted
Status
investigational
About

ABILITY Neurotech describes its platform as a fully implantable optical BCI system designed for continuous streaming of raw, lossless neural data, distinguishing itself from Bluetooth-constrained architectures on bandwidth grounds. In July 2026 the Geneva-based company completed its first-in-human neural signal acquisition, recording brain activity from patients undergoing tumor surgery at TU Munich's University Hospital Rechts der Isar. The intraoperative study was led by Drs. Wagner, Meyer and Jacob at TUM's Department of Neurosurgery and Laboratory for Translational Neurotechnology, with each patient contributing 20-30 minutes of intraoperative neural data; initial subjects were under general anesthesia during end-to-end system validation. Subsequent stages will target conscious patients performing speech and motor tasks. ABILITY spun out of the Wyss Center for Bio and Neuroengineering with early support from philanthropist Hansjorg Wyss, and is pursuing a dual EU/US regulatory pathway. This is early feasibility data only — no decoding performance metrics, electrode counts or signal-to-noise comparisons have been disclosed.

Target Conditions
neural decoding researchspeech restorationmotor restoration
Milestones
2026-07First-in-human neural signal acquisition during tumor surgery at TU Munich
FDA Regulatory Pathway
No FDA Regulatory Status

This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.

FDA Device Regulatory Guidance ↗