Methinks has announced receipt of a CE mark for its artificial intelligence (AI)-based medical imaging software, Methinks Stroke Suite, following a milestone year of development progress enabling commercialisation in Europe and assisting in emergency settings for the benefit of acute stroke patients.
Methinks Stroke Suite is the first CE-marked medical device that assists in finding large vessel occlusions (LVOs), both hyperdense and not, a company press release claims.
This radiological, computer-aided triage and notification system uses AI algorithms to identify suspected LVO on non-contrast computed tomography (NCCT) images and computed tomography angiography (CTA). The software also has the ability to detect intracerebral haemorrhages (ICH) on NCCT images. It works in parallel to the clinical workflow using the simplest CT scan, available in all hospitals, providing acute stroke care globally and will provide early, rapid and precise triaging of these patients, the release adds.
Tudor Jovin (Cooper University Health Care, Camden, USA), member of the Methinks board of directors, said: “Stroke is a leading cause of disability and death globally, and early diagnosis and treatment of ischaemic stroke due to 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 USA soon.”
The Methinks Stroke Suite has been validated across 3,800 cases from three different stroke reference hospitals. Performance and time to notification have been established through images obtained from reference centres in Europe, with high sensitivity and specificity, and an average time to notification of 87 seconds. A summary of the results is as follows:
- Validation of ICH was performed in 2,876 consecutive patient stroke suspicions, resulting in a sensitivity of 97.3%; specificity of 99.4%; and an average time to notification of 87 seconds.
- LVO on NCCT was validated in a total of 570 consecutive stroke-suspicion cases, resulting in a sensitivity of 87.2%; specificity of 87.7%; and an average time to notification of 87 seconds.
- LVO for CTA was validated in 333 consecutive stroke-suspicion cases, with a sensitivity of 92.6%; specificity of 92.9%; and an average time to notification of six minutes and 36 seconds. Analysis was performed from a variety of standard acquisition scanners.
Pau Rodriguez, CEO of Methinks, said: “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 [Food and Drug Administration] submission, and launching a Series A financing to accelerate our growth plans by leveraging and personalising imaging software.”