Sentante gains CE mark and enters FDA advisory programme for robotic stroke system
Sentante secured CE-mark approval for its multi-domain robotic platform and was accepted into the FDA’s total product life cycle advisory programme. The moves support European commercialization and planning for remote stroke thrombectomy clinical studies.
Sentante has secured CE-mark approval for its flagship device, a multi-domain robotic platform technology, and its robotic system has been accepted into the US Food and Drug Administration’s total product life cycle advisory programme. The CE mark enables the company to begin marketing and selling its robotic technology across European markets, while the FDA programme provides early, frequent and strategic engagement on clinical development, regulatory strategy, market entry and post-market evidence generation.
Sentante said the CE-mark approval marks a “major transition” from research and development to full commercial readiness following a period of “intensive” development and regulatory validation. The company said it can now partner with hospitals and healthcare providers across Europe to integrate the technology into routine clinical practice, and will focus on initial market rollout, clinician training, and expanding its commercial footprint while continuing to advance its product pipeline.
Through the FDA programme, Sentante said it will work closely with the agency to align on clinical trial design, endpoints, risk mitigation strategies and evidence requirements ahead of first-in-human studies. Initial engagement will focus on defining the pathway toward an investigational device exemption for remote stroke thrombectomy clinical studies. In parallel, the company said it is continuing to advance regulatory clearance for its peripheral vascular indication.
Sentante said this TAP acceptance follows Breakthrough Device designation granted to the system by the FDA in September 2025. The company said its multi-domain, device-agnostic endovascular platform is designed to enable expert neurointerventionists to perform thrombectomy procedures remotely, with full tactile feedback, using standard off-the-shelf catheters and guidewires.
Sentante said that, over the past year, its robotic platform advanced through multiple milestones, including a “world-first” transatlantic remote stroke thrombectomy performed on perfused human cadaver models, and a multi-day good laboratory practice live-subject study involving 24 remote thrombectomy procedures conducted from three continents. The company also recently unveiled its digital indeflator, a precision-controlled system that replaces the traditional manual indeflator used in endovascular procedures like angioplasty and stent deployment.
The company said mechanical thrombectomy has become the gold-standard treatment for large vessel occlusion stroke, but access remains “severely limited”, with more than 60% of people in the USA not having timely access to a thrombectomy-capable centre.