Onward Medical awarded US FDA Breakthrough Device designation for ARC-BCI system


Onward Medical announced recently that it has been awarded Breakthrough Device designation (BDD) by the US Food and Drug Administration (FDA) for the ARC-BCI system, which uses brain-computer interface (BCI) technology in conjunction with the company’s ARC-IM therapy to restore thought-driven lower-limb mobility after spinal cord injury (SCI).

This designation is supported by clinical data from two feasibility studies, and is the 10th BDD awarded to the company by the US FDA overall, according to a press release from Onward. The latest award gives Onward priority FDA review, the opportunity to interact with FDA experts throughout the premarket regulatory review phase, and the potential to seek additional reimbursement for its ARC-BCI system, the company also claims.

“BCI technology unlocks the transformative potential to enhance ARC-IM with thought-driven control of movement after paralysis,” said Onward chief executive officer Dave Marver. “We look forward to learning more about the potential for this combination of ARC therapy and a BCI to help people with SCI live more independently. We are also grateful to the FDA for recognising our innovations and their potential to help people with profound unmet needs.”

An implanted BCI records brain activity, capturing signals that indicate a person’s intention to move. The ARC-BCI system then uses artificial intelligence (AI) to decode those signals and translate them into specific instructions for the ARC-IM system, which converts the instructions into precise stimulation of the injured spinal cord. ARC-BCI creates a “digital bridge”, restoring communication between the brain and the body, enabling thought-driven movement after paralysis, according to Onward’s recent press release.

Onward was previously granted nine BDDs relating to multiple indications for its ARC therapy platforms, including mobility and blood pressure regulation. While all of Onward’s medical devices and therapies are currently investigational and not available for commercial use, the company says it plans to launch its first product later this year.


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