ABILITY Neurotech receives MREC approval for ALS BCI clinical trial

The clearance enables ABILITY Neurotech to move beyond intra-operative testing to long-term clinical investigation involving human participants.

ABILITY Neurotech has secured approval from the Medical Research Ethics Committee (MREC) NedMec in the Netherlands to initiate a chronic clinical trial of its fully implantable wireless brain-computer interface (BCI) in patients with amyotrophic lateral sclerosis (ALS).

The study will mark the company’s first chronic implantation in humans and will be conducted at University Medical Center Utrecht (UMC Utrecht), a European centre specialising in BCI research.

Approval was granted under the Investigational Medical Device Dossier (IMDD) procedure, allowing ABILITY Neurotech to move from intra-operative testing to a long-term clinical study involving human participants. The company says this is the first time its implantable platform will be used chronically in humans.

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