Methinks AI Secures Second FDA Clearance, Expanding its Stroke Detection Solution to Contrast Imaging

Barcelona, Spain – 9^th October 2025 – Methinks AI, an innovator in medical imaging AI, has received its second FDA 510(k) clearance of the year— this time for Methinks CTA Stroke, an AI-based software solution that accurately detects suspected large vessel occlusions (LVOs) using CT Angiography (CTA) scans. The tool demonstrated high sensitivity and specificity (98.2% and 91.6%, respectively) while including distal occlusions, up to MCA-M2.

This new clearance builds on the success of Methinks NCCT Stroke, which gained FDA clearance earlier this year for detecting suspected LVOs and intracranial hemorrhages using only non-contrast CT (NCCT) — the most widely accessible imaging method in hospitals worldwide, making stroke assessment accessible to all type of healthcare settings, including low-resource centers around the world.

Together, these solutions offer a comprehensive stroke triage platform compatible with both NCCT and CTA imaging, adaptable to a wide range of healthcare settings from advanced stroke centers to low-resource clinics.

“We’re proud to have achieved our second FDA clearance this year, a milestone that reflects the strength and maturity of our regulatory team and processes. This accomplishment demonstrates our ability to deliver advanced, accessible stroke care solutions across US hospitals,” said Pau Rodríguez, CEO at Methinks AI.
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Advanced Detection, Broader Reach

Methinks CTA Stroke stands out in the market by detecting not only proximal LVOs in the middle cerebral artery (MCA-M1) and internal carotid artery (ICA), but also more distal occlusions in the MCA-M2 segment with high sensitivity and specificity.

Seamlessly integrated into hospital systems including PACS, Microsoft Teams, and other platforms, both Methinks CTA Stroke and Methinks NCCT Stroke enable real-time collaboration between stroke teams. Clinicians can view and share imaging instantly through Microsoft Teams — no additional software required — with all the tools of an advanced medical imaging viewer, expediting treatment decisions and improving patient outcomes.

"Stroke is one of the most time-sensitive emergencies in medicine, yet too often patients suffer because critical occlusions are missed or diagnosed too late. With the addition of CTA LVO, Methinks’ platform now offers a comprehensive triage solution. It builds on its unique NCCT module, to help detect not only large, proximal occlusions, but also subtle distal ones that are frequently overlooked. This combination allows any hospital to benefit from a comprehensive stroke triage,” said Dr. Demetrius Lopes, Cerebrovascular and Comprehensive Stroke Center Surgical Director of the Advocate Health Care, US.
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Next steps: Expanding access to advanced stroke care across US centers

With the FDA clearance for both Methinks NCCT Stroke and Methinks CTA Stroke, the company is now prepared to enter the US market and support clinicians in delivering high-quality, timely care to stroke patients. Both solutions will be available at care centers across the US, increasing the quality of care and speed to treatment, becoming a life-saving solution for many patients.

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