Methinks AI announced its non-contrast computed tomography (NCCT) Stroke software has received 510(k) clearance from the US Food and Drug Administration (FDA). A press release from the company notes that this advanced software enhances the capabilities of NCCT detection, making it “the only software on the market” capable of detecting suspected large vessel occlusions (LVOs) as well as more distal occlusions like those in the M2 segment of the middle cerebral artery (MCA) with “high precision”.
“Stroke remains a leading cause of disability and death worldwide, and timely treatment initiation is critical to improving patient outcomes,” said Tudor Jovin (Cooper University Health Care, Camden, USA), a member of Methinks’ board of directors. “Methinks NCCT Stroke is a gamechanger—it brings advanced LVO detection to hospitals everywhere, whether in the USA, 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.”
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Methinks claims that, as per US FDA validation studies, its 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. The software also detects suspected intracranial haemorrhages (ICHs), offering a comprehensive stroke triage solution with a routine NCCT scan that is readily available in the majority of hospitals.
The solution is “uniquely integrated” into Microsoft Teams, enabling 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 optimised stroke workflows. In addition, results integrate smoothly into picture archiving and communication system (PACS) and hospital workflows.
Methinks goes on to note that its NCCT Stroke solution can be deployed in any hospital, including those without contrast CT capabilities or advanced imaging, which helps to reduce door-to-decision times, minimise delays in patient transfer or treatment initiation, and ensure that “no stroke case is missed”.
“Achieving FDA clearance is a defining moment for our mission and our team,” said Pau Rodríguez, chief executive officer (CEO) of Methinks. “No patient should be left behind due to decision delays or limited imaging resources, whether in the USA, Europe, or anywhere in the world. Methinks NCCT can unlock lifesaving decisions at any hospital, bringing advanced stroke triage to every corner of the globe.”
This new US FDA clearance follows Methinks’ announcement from earlier this year of a strategic partnership with Medtronic to integrate its triage software with Medtronic’s neurovascular portfolio—a collaboration that will attempt to streamline stroke workflows across hospitals in Central and Eastern Europe, Africa, Turkey and the Middle East.
