CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Brain Interchange system. The designation covers the use of direct cortical electrical stimulation to support motor recovery in people living with chronic stroke-related impairments.

The Breakthrough Device Designation is granted to medical technologies that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions. The program is designed to facilitate medical device development and review through prioritised and more interactive engagement with the FDA.

CorTec’s Brain Interchange system combines neural signal recording with adaptive stimulation in a closed-loop system. The platform is currently 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 system for stroke rehabilitation in humans.

Stroke is the leading cause of acquired long-term disability in adults worldwide. Approximately 9 million ischemic strokes occur globally each year, with an estimated 1.7 million cases in the United States and Europe alone. Over 80 per cent of stroke patients experience upper-limb impairment, and approximately 50 per cent remain permanently disabled despite standard rehabilitation. For chronic stroke patients with moderate-to-severe motor deficits whose recovery has plateaued after conventional therapy, no approved implantable treatment exists today.

“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,” said Dr Frank Desiere, CEO of CorTec. “Together with promising initial results from our first-in-human study in Seattle, as well as additional long-term data published in Nature Scientific Data1 demonstrating signal stability over 500 days, this designation provides strong momentum as we advance toward larger clinical trials. 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.”