A Unified Framework of Functional Clinical Outcomes for Implantable Motor Brain-Computer Interfaces: From Digital Motor Outputs to Critical Digital Activities.

Implantable brain-computer interfaces (iBCIs) are at a pivotal inflection point. Multiple commercial ventures are advancing toward regulatory approval, and the challenge facing the field is transitioning from demonstrating safety and feasibility to achieving regulatory approval, reimbursement by payors, and sustainable clinical integration. Central to this challenge is the urgent need for robust, valid, and reliable clinical outcome assessments (COAs) that satisfy both regulatory and payor requirements and meaningfully reflect the lived experiences of people with severe motor impairment. Without such measures, iBCIs risk stalling in the transition from early feasibility to reimbursable therapy.