EFS Neurovascular Program
Overview
The MDIC EFS Neurovascular Initiative aims to accelerate innovation in the neurovascular space by streamlining key aspects of the EFS process for novel devices in the U.S., including planning, initiation, and trial conduction. This collaborative effort brings together representatives from government agencies, industry sponsors, and clinical research sites to address the unique challenges of neurovascular research and create a more efficient pathway for bringing innovative neurovascular technologies to U.S. patients.
Objective
To accelerate patient access to innovative neurovascular technologies by streamlining development and initiation of early feasibility studies through enhanced collaboration among, industry sponsors, regulatory agencies, and clinical research sites.
Neurovascular EFS Working Group
This group focuses on improving inefficiencies in the neurovascular EFS process. By sharing best practices and working with regulatory bodies, members shape innovation and create neurovascular-specific resources that guide EFS sponsors to be better equipped to navigate the EFS regulatory pathway. Participation helps organizations advance treatments and bring solutions to patients faster.
Early Feasibility Studies in the Neurovascular Space - MDIC and Jacobs Institute
A panel hosted by MDIC and the Jacobs Institute discussed the role of EFS in neurovascular research. Experts shared insights on overcoming regulatory and design challenges, showcasing real-world examples of innovation. Supported by Philips, Siemens, and J&J, the session emphasized how collaboration helps refine new technologies and improve patient outcomes.
Accelerate EFS Toolkit
MDIC’s work within the EFS program includes tracking EFS performance metrics and developing tools and best practices for EFS sponsors and clinical researchers. All resources and tools within the Accelerate EFS toolkit have been compiled by experts, ensuring that the guidance is rooted in deep knowledge and practical experience.
