StoryRegulatory
CorTec receives FDA Breakthrough for Brain Interchange in stroke recovery
CorTec announced FDA Breakthrough designation for Brain Interchange for stroke rehabilitation. The designation covers direct cortical electrical stimulation to support motor recovery in chronic stroke patients.
- FDA Breakthrough designation for stroke motor rehabilitation.
- First BCI worldwide designated for stroke motor recovery.
- Based on clinical trial showing motor recovery in implanted patients.
- Expedited FDA review path enabled for commercialization.