CorTec has received “Breakthrough Device Designation” from the US Food and Drug Administration for its Brain Interchange system, a fully implantable brain-computer interface (BCI) designed to support motor recovery in stroke patients.
The designation applies to the use of direct cortical electrical stimulation to treat chronic stroke-related impairments, marking what the company describes as the first BCI globally to receive this recognition specifically for stroke motor rehabilitation.
The FDA’s Breakthrough Device program is intended for technologies that may provide more effective treatment for life-threatening or irreversibly debilitating conditions, offering developers prioritized review and closer interaction with regulators. [Read more…] about CorTec receives FDA ‘breakthrough’ designation for brain-computer interface in stroke rehabilitation