Consensus Statement for the Assessment of iBCI Endpoints for Clinical Utility

Workgroups:  Clinical Study Endpoints; Payor Interactions and Device Categorization

Date Updated: 1 October 2026

Authors: Kurt Haggstrom, Catherine Lang, David McMullen, David Moses, Vivek Pinto, David Putrino, Korak Sarkar, Mijail Serruya, Jayme Strauss, Mariska Vansteensel, Cristin Welle

Overview:

The purpose of this consensus statement is to provide an initial assessment of the potential clinical endpoints for iBCIs from the perspective of clinical utility. There are several outside and internal efforts which are described that lead to the issuing of this assessment and statement. Although there is more work to be done to get to a definitive consensus of endpoints for regulatory and payor decision-making, this early consensus statement provides the multi-stakeholder view of the direction for future endpoints development, analysis and reporting.

Audience and Application:

The primary audience includes payors, regulators, researchers and developers of iBCIs.