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Onward wins FDA breakthrough nod for use of neurostim with brain-computer interface

Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology.
Onward wins FDA breakthrough nod for use of neurostim with brain-computer interface

ARC-BCI uses BCI technology in conjunction with ARC-IM neurostimulation. It aims to restore thought-driven lower limb mobility after spinal cord injury (SCI). The BCI system uses AI to decode brain signals and translate them into specific instructions for the neurostimulation system. This converts the instructions into precise spinal cord stimulation.

The company describes the result as a “digital bridge” that restores communication between the brain and the body. It can enable thought-driven movement after paralysis.

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