Synchron has paused enrollment in clinical trials of its second-generation brain implant after the device failed to perform as expected in initial participants, WIRED reported Nov. 12.
Synchron said in a statement to WIRED that it identified a performance issue involving the lead, the cable that carries signals from the Stentrode to the implanted electronics. The company said the issue does not involve the Stentrode itself and that no safety issues related to the device have been identified.
The brain-computer interface company’s Stentrode is designed to let people control digital devices with brain signals. Synchron said the pause was a company decision, not an FDA-directed action.
Two of the five U.S. trial sites WIRED was able to reach confirmed that recruitment is on hold. A coordinator at one site said the pause was not safety-related.
Some participants have already received the second-generation device, which has fewer electrodes and connects wirelessly via Bluetooth, according to WIRED. Synchron said it will continue to support participants with Stentrode devices across their lifetime.
The company said it has brought lead design and manufacturing in-house and will upgrade the entire Stentrode system before resuming enrollment.
Synchron is also restructuring its operations, WIRED reported, eliminating jobs and reducing its New York footprint while building a team in San Diego. That team will design and manufacture the upgraded lead and Stentrode, as well as a separate device the company has not yet revealed. WIRED did not report how many jobs are affected.
The trials are key to advancing the Stentrode into a larger pivotal trial, which is needed for FDA marketing approval. WIRED reported Synchron was estimated to have a nearly $1 billion valuation after closing a $200 million funding round in fall 2025.
