CE marked certification for AI stroke software, Methinks

Brain scan of stroke victim

Digital health company Methinks - which specialises in early detection and management of Acute Stroke (AS) by using artificial intelligence (AI) – has announced (PDF) that it has received CE-marked certification for its medical imaging software, the Methinks Stroke Suite.

Methinks’ Stroke Suite provides early, automated detection of large vessel occlusions (LVO), both hyperdense and not, from non-contrast computed tomographies – providing assistance in emergency settings for the benefit of AS patients. It is the first CE marked medical device to do so.

AS is a serious, life-threatening medical condition that affects circa 17 million people globally each year. Early detection is crucial for improvement of a patient’s chance of recovery, reducing permanent disability, and also reducing the need for extensive rehabilitation.

LVO is the obstruction of large, proximal cerebral arteries. It accounts for approximately 30% of Acute Ischaemic Stroke (AIS) patients, according to the National Library of Medicine.

The Methinks Stroke Suite is an AI-based software. A radiological computer-aided triage and notification system that uses AI algorithms to identify suspected LVO on non-contrast computed tomography (NCCT) images and computed tomography angiography (CTA), additionally the software is able to detect Intracerebral haemorrhages (ICH) on NCCT images.

Working in parallel with clinical workflow, using the simplest CT scan available in all hospitals which provide AS care around the world, the Methinks Stroke Suite is said to permit early, rapid, and precise triaging of AS patients.

Validated with 3,800 cases from three different stroke reference hospitals, it is thought the software will provide valuable assistance to trained physicians, supporting crucial treatment and triaging in emergency cases. Performance and time to notification established through the images of ICH and LVO showed high sensitivity (97.3% and 87.2%, respectively) and specificity (99.4% and 87.7%, respectively) and an average time to notification of 1.27 minutes for both.

Methinks’ CEO, Pau Rodriguez, noted: “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 personalising imaging-software.”

Meanwhile, Tudor Jovin - chair of neurology at Cooper University Health Care in Camden, New Jersey in the US, and a 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 large vessel occlusion, which is the most severe type of stroke, [is crucial].”

Jovin continued: “This disruptive technology […] 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.”

The news follows a milestone year of development progress for Methinks and the CE marked certification will enable commercialisation in Europe.

Another company working in the stroke field is Astrocyte Pharmaceuticals, with whom pharmaphorum spoke at JP Morgan Week this year, discussing the brain cell it’s named after, and the treatments it is currently pursuing in a phase I study. To learn more, watch the video here.

Image sourced from Freepik.com.