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FDA approves Synchron brain-computer interface for human trials

The implant company has received FDA approval to conduct human clinical trials. Synchronous plans to begin an early feasibility study for its Stentrode implant later this year at Mount Sinai Hospital, New York, with six patients. The company said it will evaluate “the safety and efficacy of the device in severely paralyzed patients.”

Synchron has received an FDA green light over competitors like Elon Musk. Before such companies can sell BCI commercially in the US, they need to prove that the devices are working and safe. The FDA will provide guidance on testing BCI devices for patients with paralysis or amputation. during the webinar on Thursday.

Another clinical trial of Stentrod is ongoing in Australia. Four patients received an implant that is used “to transmit data from the motor cortex to control digital devices,” said Synchron. According to data published in the Journal of NeuroInterventional Surgery, two patients were able to control their computer with their thoughts. They completed work assignments, sent text messages and emails, and did online banking and shopping.

According to Synchron, it takes about two hours to implant a Stentrode in a minimally invasive procedure. The device is implanted through a blood vessel in the lower neck and inserted into the brain. Synchron CEO Thomas Oxley told the device will be available for purchase within three to five years.

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