Methinks Gains EU Nod for AI Stroke Triage Software

Methinks, a digital health company specializing in acute stroke early detection and management using artificial intelligence (AI) has received CE mark approval for its Methinks Stroke Suite medical imaging software.
 
According to the company, the Methinks Stroke Suite is the first CE-marked medical device to help find large vessel occlusions (LVO) both hyperdense and not. As cited in the National Library of Medicine, LVO accounts for about 30% of acute ischemic stroke patients.
 
The AI-based software is a radiological computer-aided triage and notification system that leverages AI algorithms to spot suspected LVO on non-contrast computed tomography (NCCT) images and computed tomography angiography (CTA). The software can also detect intracerebral hemorrhages on NCCT images. The software works in tandem with clinical workflow using the simplest CT scan available in hositals.
 
The Methinks Stroke Suite has been validated with 3,800 cases from three different stroke reference hospitals.
 
Pau Rodriguez, CEO of Methinks, told the press: “We are delighted with the CE mark approval for our medical imaging software, Methinks Stroke Suite, which paves the way to enhance stroke patient outcomes by decreasing detection time and reducing disabilities. Our software has the potential to be used in every hospital globally to improve the standard of care of patients. The approval comes at a pivotal time ahead of US FDA submission and launching a series A financing to accelerate our growth plans by leveraging and personalizing imaging-software.”
 
Tudor Jovin, Chair of Neurology at Cooper University Health Care in Camden, N.J. and Member of Methinks Board of Directors added: “Stroke is a leading cause of disability and death globally and early diagnosis and treatment of ischemic stroke due to large vessel occlusion (LVO) which is the most severe type of stroke. Early detection and diagnosis are crucial to improving a patient’s outcomes. This disruptive technology is capable of detecting LVO from NCCT images and will undoubtedly have an impact on our clinical practice due to the potential of significantly, shortening the time from stroke onset to reperfusion in a large number of patients with LVO stroke. As an interventional neurologist, I look forward to having the product available in the U.S. soon.”
 
Performance and time to notification has been established through images obtained from reference centers in Europe, with high sensitivity and specificity and an average time to notification of 1:27 minutes.