FDA clears Synchron's brain-computer interface device for human trials

A company that makes an implantable brain-computer interface (BCI) has been given the go-ahead by the Food and Drug Administration to run a clinical trial with human patients. Synchron plans to start an early feasibility study of its Stentrode implant later this year at Mount Sinai Hospital, New York with six subjects. The company said it will assess the device’s “safety and efficacy in patients with severe paralysis.”

Synchron received the FDA’s green light ahead of competitors like Elon Musk’s Neuralink. Before such companies can sell BCIs commercially in the US, they need to prove that the devices work and are safe. The FDA will provide guidance for trials

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