The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to CorTec’s Brain Interchange system for the use of direct cortical electrical stimulation to support motor recovery in people living with chronic stroke-related impairments.
The designation is intended to facilitate development and review by prioritizing and making engagement with the FDA more interactive. Brain Interchange is a fully implantable, wireless, bidirectional brain-computer interface that combines neural signal recording with adaptive stimulation in a closed-loop system; it is being evaluated in an FDA-approved IDE study at the University of Washington in Seattle, marking the first clinical investigation of a fully implantable wireless BCI for stroke rehabilitation in humans.
CorTec reports that the first two patients were implanted at Harborview Medical Center in July 2025 and February 2026, with the first patient showing meaningful neurological improvement, including recovery of upper-limb motor function that had plateaued after conventional therapy.
The company cites global stroke figures of about 9 million ischemic strokes annually, an estimated 1.7 million cases in the United States and Europe, and that over 80% of stroke patients experience upper-limb impairment, while roughly 50% remain permanently disabled despite standard rehabilitation. The company also cites peer-reviewed data demonstrating more than 500 days of continuous signal stability and says the platform is being evaluated for epilepsy and other indications.
