Photo: fotograzia/Getty Images
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Germany-based brain-computer interface company CorTech GmbH for its Brain Interchange system used for stroke-related impairments.
Brain Interchange is a brain-computer interface (BCI) system and investigational device designed to restore movement in individuals who have suffered neurological injury due to a stroke.
According to the company, the device works by using direct cortical electrical stimulation. It establishes a direct channel of communication between the brain and external rehabilitation technologies and combines neural signal recording with adaptive stimulation in a closed-loop system.
"Only a few BCI companies worldwide – including Neuralink, Synchron, or Blackrock Neurotech – have received Breakthrough Device Designation to date. Achieving this designation is a defining milestone for CorTec and underscores the potential of our Brain Interchange system to address the significant unmet need in stroke rehabilitation," Frank Desiere, CEO of CorTec, said in a statement.
"We believe CorTec occupies a unique position in the global BCI landscape, combining a fully implantable, bidirectional closed-loop platform with a therapeutic approach focused on restoring motor function after stroke."
THE LARGER TREND
In 2024, CorTec received FDA Investigational Device Exemption and IRB approval from the University of Washington, which cleared the way for the technology to become the first human implant of a German-made fully implantable brain-computer interface in the U.S.
In July of last year, the company announced the successful implantation of its Brain Interchange system performed at Harborview Medical Center in Seattle, which was part of an FDA-approved trial led by researchers from UCLA and the University of Washington.
In February of this year, CorTec successfully implanted its BCI system into a second patient at Harborview Medical Center.
Other companies that have received FDA Breakthrough Device designation for brain-computer interface technology include Elon Musk's Neuralink, which, in 2024, received the FDA designation for Blindsight.
Blindsight is an implant that aims to restore vision in individuals who are blind by inserting a microelectrode array into the visual cortex of the brain. The company said the array then activates neurons, which then provide the individual with a visual image.
Last year, Neuralink received Breakthrough Device designation for its speech restoration BCI, which aims to restore communication for individuals with severe speech impairment.
Synchron received the designation for its minimally invasive BCI Stentrode, which allows individuals to control digital devices using their thoughts, and Precision Neuroscience won the Designation for its Layer 7 Cortical Interface.
