Brain-computer interface receives FDA 'breakthrough' designation: Page 2 of 2

September 08, 2020 //By Rich Pell
Brain-computer interface receives FDA 'breakthrough' designation
Neurovascular bioelectronics medicine company Synchron has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its fully-implantable medical device that can translate brain activity or stimulate the nervous system from the inside of a blood vessel, without the need for open brain surgery.
fully-internalized, wireless telemetry solution implanted in the chest provides high-resolution neural data transmission, and is the final component of the system.

Safety and efficacy data from a currently-active first-in-human clinical trial will be used to finalize the protocol for an FDA-enabling study that will guide evaluation for U.S. marketing approval. Future research will evaluate the use of the Stentrode in patients with paralysis due to spinal cord injury, ALS, stroke, and muscular dystrophy.

According to the company, pre-clinical studies have demonstrated the Stentrode's long-term safety as well as its ability to pick up specific electrical frequencies emitted by the brain. The results have been published in scientific journals including Nature Biotechnology, Nature Biomedical Engineering, and the Journal of Neurosurgery.

Synchron

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