CE mark for Methinks software aiming to reduce stroke risks

Methinks, a digital health company that specializes in early detection and management of acute stroke (AS), using artificial intelligence (AI), announced that it has received CE mark for its medical imaging software, Methinks Stroke Suite.

The company said this was following a milestone year of development progress, enabling commercialization in Europe and to assist in emergency settings for the benefit of AS patients.

When a major artery in the brain is blocked, an LVO stroke can occur, these are a type of ischemic stroke. This type of blockage happens in the internal carotid artery (ICA) or ICA terminus – both major cerebral vessels in the brain. Risk factors are like those for other strokes such as hypertension, hyperlipemia, diabetes and smoking.

The suite assists in finding LVOs both hyperdense and not. LVO accounts for approximately 30% of Acute Ischaemic Stroke (AIS) patients as cited in the National Library of Medicine​.

AS is a serious life-threatening medical condition that affects approximately 17 million people globally each year. Methinks says early detection is vitally important to improve the chance of recovery, reduce permanent disability and reduce the need for extensive rehabilitation.

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 submission and launching a series A financing to accelerate our growth plans by leveraging and personalizing imaging-software.”                                                

The AI-based software is a radiological computer aided triage and notification system which uses AI algorithms to identify suspected LVO on non-contrast computed tomography (NCCT) images and computed tomography angiography (CTA). In addition, the software also can detect Intracerebral haemorrhages (ICH) on NCCT images. The software works in parallel to the clinical workflow using the simplest CT scan which is available in all hospitals providing AS care globally and will provide early, rapid and precise triaging of AS patients.

The company says the suite has the potential to be a valuable tool which will assist trained physicians to support crucial treatment, triaging in emergency cases by providing notifications of suspected ICH and LVO cases. The device has been validated with 3,800 cases from three different stroke reference hospitals.

Tudor Jovin, chair of neurology at Cooper University Health Care in Camden, USA, is a member of Methinks board of directors. He said: “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 can detect 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 many patients with LVO stroke. As an interventional neurologist, I look forward to having the product available in the US soon.”