Digital health company Methinks has secured CE mark for its Methinks Stroke Suite medical imaging software.
The Methinks Stroke Suite is claimed to be the first CE-marked medical device that can help locate large vessel occlusions (LVO), both hyperdense and not, from non-contrast computed tomographies (NCCT) images.
The radiological computer-aided triage and notification system uses artificial intelligence (AI) algorithms to detect suspected LVO on NCCT images as well as computed tomography angiography (CTA).
The AI-based software also has the potential to identify intracerebral haemorrhages (ICH) on NCCT images.
According to the company, the software works in parallel with clinical workflows and leverages CT scans that are available in all hospitals.
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Furthermore, the ability of the device has been validated in 3,800 cases from three different stroke reference hospitals.
Methinks CEO Pau Rodriguez 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 personalising imaging software.”
Based in Barcelona, Spain, Methinks is involved in the development of AI-based medical imaging software to identify cerebral artery occlusions and haemorrhages.