Tuesday, September 8, 2026
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Tag: UMC-Utrecht

3 articles

Industry News

CorTec wins a second FDA Breakthrough Device Designation for its Brain Interchange implant, this one for communication

German BCI operator CorTec GmbH announced on 31 August 2026 that FDA has granted a second Breakthrough Device Designation for its Brain Interchange implant, covering computer cursor control for people with non-progressive quadriplegia. The company's first Breakthrough Designation, in April 2026, covered stroke motor rehabilitation. Both designations apply to the same fully implantable, wireless, battery-free, bidirectional closed-loop platform with non-penetrating cortical surface electrodes. CorTec is now running two parallel FDA regulatory processes on identical hardware. The European regulatory route (EMA, CE Mark) is absent from the announcement.

Sep 1

Industry News

ABILITY Neurotech opens Munich intraoperative BCI trial

Geneva-based ABILITY Neurotech has run a first-in-human intraoperative trial of its fully implantable brain-computer interface at TUM University Hospital in Munich, with up to five brain tumour surgery patients recorded over 20 to 30 minute sessions. A chronic ALS implant with UMC Utrecht and TU Graz is scheduled for Q4 2026. The device is an ECoG surface-electrode implant powered inductively through the scalp, using a laser-based optical link to move raw high-bandwidth neural data through intact skin, not an optical neural-sensing BCI.

Aug 22

Industry News

ABILITY Neurotech reaches first-in-human at TUM Munich

On Tuesday 21 July 2026, Geneva-based ABILITY Neurotech announced the first-in-human recording of its fully implantable, batteryless brain-computer interface at TUM University Hospital Rechts der Isar in Munich. The device is a 128-channel sub-scalp ECoG array with a laser-based transcutaneous optical data link streaming raw neural signals through the scalp at 50 megabits per second. The first cohort is up to five brain-tumour surgery patients recording 20 to 30 minutes of intraoperative data each. The company's separate chronic implantation trial in ALS patients at UMC Utrecht, cleared by Dutch regulators on 26 May 2026, has not yet performed a surgery.

Jul 24