Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology.
ARC-BCI uses BCI technology in conjunction with ARC-IM neurostimulation. It aims to restore thought-drive 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.
Onward used clinical data from two feasibility studies to support the breakthrough nod. The company also announced the first implant of this technology in a study evaluating upper extremity function restoration last year.
This marks the 10th FDA breakthrough nod received by Onward Medical. It grants the company priority review and allows it to interact with FDA experts throughout the pre-market regulatory review phase. It can also lead to additional reimbursement opportunities for the technology.
“Brain-computer interface technology unlocks the transformative potential to enhance ARC-IM with thought-driven control of movement after paralysis,” said Onward Medical CEO Dave Marver. “We look forward to learning more about the potential for this combination of ARC Therapy and a BCI to help people with spinal cord injury live more independently. We are also grateful to the FDA for recognizing our innovations and their potential to help people with profound unmet needs.”
Onward featured on our 2023 list of 5 brain-computer interface companies you need to know.