Methinks announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for Methinks computed tomography angiography (CTA) Stroke, an artificial intelligence (AI)-based software solution intended to accurately detect suspected large vessel occlusions (LVOs) using CTA scans. This marks the company’s second FDA 510(k) clearance of 2025 after its non-contrast computed tomography (NCCT) Stroke software gained approval from the US regulator in July.
Methinks states in a press release that its CTA Stroke tool has demonstrated high sensitivity and specificity (98.2% and 91.6%, respectively) across stroke cases including distal occlusions up to the M2 segment of the middle cerebral artery (MCA).
This new clearance builds on the US FDA clearance earlier this year of Methinks NCCT Stroke for detecting suspected LVOs and intracranial haemorrhages (ICHs) using only NCCT imaging. 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 centres to low-resource clinics, according to Methinks.
“We’re proud to have achieved our second US FDA clearance this year, a milestone that reflects the strength and maturity of our regulatory team and processes,” said Methinks chief executive officer (CEO) Pau Rodríguez. “This accomplishment demonstrates our ability to deliver advanced, accessible stroke care solutions across US hospitals.”
“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,” added Demetrius Lopes (Advocate Health Care, Chicago, USA). “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.”
Methinks claims that its CTA Stroke software “stands out in the market” by detecting not only proximal LVOs in the MCA-M1 and internal carotid artery (ICA), but also more distal occlusions in the MCA-M2 segment, with high sensitivity and specificity. And, with the US FDA clearance of Methinks NCCT Stroke and Methinks CTA Stroke, the company says it is now prepared to enter the US market and support clinicians in delivering high-quality, timely care to stroke patients, with both solutions set to be made available at care centres across the USA.
