ONWARD Medical, a medical technology firm specializing in spinal cord stimulation therapies, has secured a position in the U.S. FDA's Total Product Lifecycle Advisory Program (TAP) for its brain-computer interface (BCI) technology. With recent FDA Breakthrough Device Designation (BDD) for its ARC-BCI System, it becomes the second BCI company to join TAP, facilitating strategic collaboration among regulatory bodies, healthcare professionals, and stakeholders to expedite the development and accessibility of advanced medical devices. Participation in TAP ensures expedited premarket interactions, early risk mitigation, and a streamlined review process, promising swift delivery of safe and effective therapies to individuals with spinal cord injury (SCI) and related disabilities.
ONWARD Medical's ARC-BCI System integrates BCI technology with ARC-IM Therapy, offering promising avenues for mobility restoration post-SCI. Groundbreaking feasibility studies demonstrated thought-driven limb movement restoration after paralysis, marking significant milestones in medical history. Leveraging a decade of scientific research and securing ten Breakthrough Device Designations, ONWARD Medical's ARC Therapy platform represents a paradigm shift in spinal cord stimulation. ONWARD Medical remains committed to advancing SCI treatment, supported by strategic partnerships and a global presence across Europe and the United States.
