Case Studies
Artiria Medical
Overview
Artiria Medical, an innovator in neurovascular technology, set out to bring its SmartGUIDE™ 014 to market—a real-time deflectable guidewire designed to improve navigation through complex vascular anatomies during stroke interventions. To support this ambition, Artiria partnered with Psephos Biomedica, a specialist consultancy in clinical and regulatory strategy.
The Challenge
Bringing a novel medical device to market—particularly in the neurovascular space—requires navigating highly complex regulatory frameworks. Artiria needed to:
Achieve FDA 510(k) clearance in the United States
Develop a robust clinical and regulatory strategy
Align with both US and European regulatory requirements
Ensure a smooth and credible submission process
The stakes were high, with regulatory success critical to both market entry and investor confidence.