Image Credit: Synchron
Synchron has voluntarily paused enrollment in trials of its second-generation Stentrode brain-computer interface because of a performance problem with the lead connecting the endovascular electrode array to the implanted electronics. In a statement reported by WIRED on November 12, the company said it had identified no associated safety issues and that the pause was not FDA-directed. Synchron is bringing lead design and manufacturing in-house and plans system upgrades before enrollment resumes. The available information does not establish the failure mechanism, its frequency, or the changes needed to restore performance.