CorTec Gets FDA Breakthrough Nod for Brain Interchange BCI System

CorTec, a pioneer in fully implantable brain-computer interfaces (BCI), has been awarded breakthrough device status for its Brain Interchange system.

The designation covers use of direct cortical electrical stimulation to support motor recovery in patients living with chronic stroke-related impairments. The Brain Interchange system combines neural signal recording with adaptive stimulation in a closed-loop system.

The platform is being assessed in an FDA-approved IDE study at the University of Washington in Seattle. It marks the first clinical investigation of a fully implantable, wireless BCI system for stroke rehabilitation in humans, CorTec said.

Chronic stroke patients with moderate-to-severe motor deficits whose recovery has plateaued after conventional therapy currently have no approved implantable treatment options.

“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 Data 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.”

A number of BCI systems have received Breakthrough Device Designation and are restricted to enable patient communication by controlling digital devices through thought. Brain Interchange is being developed as a fully implantable, bidirectional device, allowing brain-based communication and also therapeutic stimulation.

As of today, no other BCI company has a Breakthrough Device Designation for this indication. The platform is also being evaluated for epilepsy, with further indications of paralysis and depression under development.

“The Breakthrough Device Designation enables more frequent and structured engagement with the FDA as we advance our development program,” said Mara Assis, Head of Regulatory Affairs & Quality Management at CorTec. “Our regulatory strategy has followed a stepwise approach, from prior device clearance to IDE approval and successful human implantations. This designation will help accelerate planning of clinical trials and support the next regulatory milestones.”