CorTec said the U.S. Food and Drug Administration has accepted its Brain Interchange™ brain‑computer interface into the agency's Total Product Life Cycle Advisory Program (TAP) and that the device recently also received FDA Breakthrough Device Designation. The company announced the regulatory steps on April 23, 2026 and reported a third patient implant in the NIH‑funded, FDA‑authorized clinical study at Harborview Medical Center in Seattle, bringing the cohort to three.
TAP offers enrolled companies a dedicated FDA liaison, accelerated feedback on study design and regulatory strategy, and early engagement with payers and clinicians including the Centers for Medicare & Medicaid Services (CMS). CorTec said TAP acceptance gives structured support from early clinical work through market access and reimbursement planning for the device's intended use in stroke motor rehabilitation.
The ongoing U.S. study is funded by the National Institute of Neurological Disorders and Stroke (award UH3NS121565), the company said. The first U.S. participant received the implant in July 2025; CorTec reports that implant has remained operational for nine months with stable wireless sensing and cortical stimulation. The company also cites a 2025 Nature Scientific Data paper documenting more than 500 days of continuous operation for its platform in prior work.
“TAP acceptance places CorTec at the forefront of a field dominated by U.S. players and confirms that European deep‑tech innovation can compete at the highest level of global medtech development,” CorTec CEO Dr. Frank Desiere said in the company statement. He added that closer FDA engagement and earlier payer interaction will help build clinical evidence and reimbursement frameworks for the therapy class.
Jeffrey G. Ojemann, MD, Vice Chair and Professor of Neurological Surgery at the University of Washington, said: "We now have three patients in the study, and each one adds a new dimension to what we can learn." CorTec CTO Dr. Martin Schuettler commented, "Nine months of reliable, fully implanted brain sensing and stimulation without compromise in performance is far from a given in this field."
Brain Interchange™ is a fully implantable, wireless, bidirectional closed‑loop BCI designed for long‑term neural sensing and adaptive cortical stimulation. CorTec said the platform is also being evaluated in other clinical and research programs including epilepsy and communication restoration.
More information is available from CorTec and the Brain Interchange project at brain-interchange.com.
Photo credit: ml.globenewswire.com
Tags: brain–computer interface, stroke motor rehabilitation, FDA Total Product Life Cycle Advisory Program (TAP), Breakthrough Device Designation, clinical trial
Topics: Brain–computer interfaces, Neuromodulation, Neurotech industry & startups