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Synchron Pauses Trials of Its Brain Implant Due to Performance Issues
Synchron has paused recruitment for trials of its newer brain implant after identifying a performance problem with a cable that carries signals from the implant to its electronics. The company says the issue is not safety-related and does not involve the Stentrode itself; it is upgrading the whole system before restarting enrolment.
The Brooklyn-based company is also restructuring, cutting jobs and reducing its New York presence while building a team in San Diego to develop upgraded hardware and a separate, undisclosed device. Its first-generation Stentrode helped ten volunteers in the US and Australia control digital devices, while the newer wireless version is being evaluated at trial sites in the US, Australia and Canada. The trials are an important step towards a larger study needed for US marketing approval.
In short
- Synchron paused enrolment over a cable performance issue.
- The company says no safety concerns have been identified.
- Upgraded hardware is needed before trials resume.