The U.S. Food and Drug Administration (FDA) has granted breakthrough device status to CorTec's brain-computer interface (BCI) system.
This designation is awarded to innovative medical solutions that effectively treat or diagnose serious diseases. The FDA's program accelerates the development and evaluation of technologies, ensuring patients quick access to vital therapies without compromising safety standards.
The status aims to facilitate the development and review of medical devices through prioritized and more interactive engagement with the FDA. It applies to the use of direct electrical stimulation of the cerebral cortex. The technology is designed to restore motor functions in individuals with chronic motor impairments caused by stroke.
CorTec's brain-computer device combines neural signal recording with adaptive stimulation in a closed-loop system. The platform is undergoing FDA-approved clinical trials at the University of Washington in Seattle.
"This is the first clinical analysis of a fully implantable wireless BCI system for stroke rehabilitation in humans," the announcement states.
Acute cerebrovascular accidents are the leading cause of acquired long-term disability in adults. Approximately 9 million cases of ischemic stroke are reported worldwide each year, with about 1.7 million occurring in the U.S. and Europe.
More than 80% of patients experience upper limb dysfunction, and around 50% remain permanently disabled.
Currently, there is no approved implantable treatment for patients with chronic stroke and moderate to severe motor impairments whose recovery has plateaued after traditional therapy.
"Today, only a few BCI companies worldwide have received breakthrough device status, including Neuralink, Synchron, and Blackrock Neurotech. This milestone is significant for CorTec and highlights the potential of our system to meet a substantial need for stroke rehabilitation," said CEO Frank Desiere.
He added that the system shows signal stability for up to 500 days.
Several BCI technologies from other companies enable communication through digital device control via thought. CorTec is developing a bidirectional solution with therapeutic neurostimulation for physical rehabilitation.
This unique development has been highlighted as a breakthrough device by the company.
In addition to stroke recovery, the platform is being tested for epilepsy treatment. Efforts are also underway to expand its indications to include assistance for paralysis and depression.
Notably, BCI user Galen Buckwalter has learned to create music using only his thoughts.