Methinks AI receives FDA 510(k) clearance to expand the frontiers of Non-Contrast CT for stroke triage

It is the first and only LVO detection software capable of detecting LVOs up to the MCA-M2 level using NCCT

BARCELONA, SPAIN, July 1, 2025 /EINPresswire.com/ -- While reducing false-negative errors by nearly half according to FDA validation studies.

Methinks AI, a pioneer in AI-driven radiological triage and acute care coordination, announces that its Methinks NCCT Stroke software has received clearance from the U.S. Food and Drug Administration (FDA). This advanced software enhances the capabilities of non-contrast CT (NCCT) detection, becoming the only software on the market capable of detecting suspected Large Vessel Occlusions (LVOs) including more distal occlusions such as those in the MCA-M2 segment with high precision.

According to FDA validation studies, Methinks’ NCCT Stroke software ​delivers superior ​accuracy in detecting suspected LVOs reducing false-negative errors by nearly ​50%​ compared to the most accurate NCCT LVO triage tool ​currently available for the same occlusion types. ​​T​his is​ a​​ ​crucial ​landmark in stroke care, as it reliably contributes to faster transfer and treatment decisions. ​The software also detects suspected intracranial haemorrhages (ICH), offering a comprehensive stroke triage solution with a routine NCCT scan​, readily available in virtually any hospital.​​ ​

This FDA 510(k) clearance significantly advances acute care workflows in the U.S. and globally. It reinforces Methinks AI’s commitment to expanding access to advanced stroke assessment and treatment using the most widely available imaging modality.

Methinks NCCT Stroke delivers breakthrough performance in detecting both suspected LVOs from standard NCCT scans, including those in the middle cerebral artery (MCA) segment M1 and the internal artery (ICA), as well as more distal occlusions in the MCA-M2 segment, and intracranial haemorrhages (ICH).

Uniquely integrated into Microsoft Teams, the solution enables real-time image sharing and clinical collaboration across stroke teams on a secure, widely adopted platform. This end-to-end system supports faster decisions, improved coordination, and optimizes stroke workflows — critical when every minute counts. Results also integrate smoothly into PACS and hospital workflows.

The Methinks solution can be deployed in any hospital, including those without contrast CT capabilities or advanced imaging. This helps reduce door-to-decision times, minimize delays in patient transfer or treatment initiation, and ensure that no stroke case is missed. This capability has far-reaching impact, especially in regional areas and healthcare settings with limited access to specialized stroke care, in the U.S. and worldwide.

METHINKS NCCT STROKE EMPOWERS GLOBAL ACCESS TO STROKE TREATMENT

“Achieving FDA clearance is a defining moment for our mission and our team,” said Pau Rodríguez, CEO of Methinks AI. “No patient should be left behind due to decision delays or limited imaging resources, whether in the U.S., Europe, or anywhere in the world. Methinks NCCT can unlock life-saving decisions at any hospital, bringing advanced stroke triage to every corner of the globe.”

“Methinks NCCT Stroke brings advanced LVO detection to hospitals everywhere, whether in the United States, Europe, or regions with limited imaging resources. This kind of innovation could significantly shorten the time to treatment and ultimately save lives by ensuring that stroke patients get the care they need as quickly as possible,” said Tudor Jovin, MD, Chair of Neurology at Cooper University Health Care and member of Methinks AI’s Board of Directors.

Microsoft Teams is already widely used in hospitals across the U.S., and Europe, and Methinks AI’s cloud-based infrastructure, deployed in Azure, reinforces global scalability. It offers seamless compatibility with any CT scanner worldwide, along with secure, scalable and workflow-friendly implementation options for healthcare providers around the world.

The new clearance arrives two months after Methinks AI announced a strategic partnership with Medtronic, the leading global healthcare technology company, to integrate Methinks’ triage software with Medtronic’s neurovascular portfolio. This collaboration will streamline stroke workflows across hospitals in Central and Eastern Europe, Africa, Türkiye and Middle East.

About Methinks AI

Founded in 2016, Methinks AI is a commercial-stage, VC-backed digital health company specializing in AI-powered imaging assessment solutions for neurovascular emergencies. Its mission is to provide universal and timely medical assistance through advanced, accessible technology. Methinks AI is the first company to receive CE mark for AI-based LVO assessment support on non-contrast CT. This achievement contributes to the evolution of early stroke care globally.

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