Brainomix Targets US Expansion with the Launch of its Cutting-Edge Stroke AI Platform Following Series of FDA Clearances

Brainomix, the AI-powered medtech solutions company, has heralded its continued US expansion with the launch of its full suite of FDA-cleared modules in its Brainomix 360 platform for stroke care.

The US launch, which included its previously announced FDA cleared e-ASPECTS module, represents a comprehensive platform designed to support clinicians and their imaging-based treatment decisions at all points across the stroke pathway, from simple imaging to more advanced imaging.

Long established as a market leader in Europe and a pioneer in the development of innovative stroke AI solutions, the company will continue to introduce its transformative technology to more US stroke centers.

The Brainomix 360 platform is powered by state-of-the-art AI algorithms that provide real-time interpretation of brain scans to aid treatment and transfer decisions for stroke patients, with an aim towards enabling more patients to receive the right treatment, in the right place, at the right time.

The launch included Brainomix exhibiting at the Society of Vascular and Interventional Neurology (SVIN) Conference in Miami, with Dr Waleed Brinjikji, Professor of Radiology and Neurosurgery at the Mayo Clinic in Rochester, Minnesota, providing a keynote presentation on his experience with the Brainomix 360 platform.

“We have been collaborating with the Brainomix team around numerous research projects over the past couple of years, including a recent study that validated the performance of their e-ASPECTS module,” noted Dr Brinjikji. “The results showed that the accuracy of ASPECTS scoring by physicians improved across disciplines and levels of experience, which makes the e-ASPECTS module a powerful tool for clinicians across the US who are managing stroke patients.”

“We are delighted to have the opportunity to introduce our Brainomix 360 platform to more and more US stroke networks, and to showcase the extensive validation of our technology, a good portion of which was conducted in the US at such institutions as the Mayo Clinic, Emory University, Mount Sinai in New York, and UCLA” said Dr Michalis Papadakis, co-founder and CEO of Brainomix.

The recent FDA clearances included Brainomix 360 e-CTP and Brainomix 360 e-MRI, both software modules that can support thrombolysis and thrombectomy treatment decisions, particularly for late-window patients who present to hospital more than 6-12 hours after stroke onset.

Brainomix 360 Triage LVO and Brainomix 360 Triage ICH are two new notification tools, which send real-time alerts to clinicians when a bleed or large vessel occlusion (LVO) is suspected. The presence of LVO can be a key determinant when deciding a patient’s eligibility for mechanical thrombectomy.

Brainomix has established commercial operations in the US and will continue to expand as it rolls out its products across US hospital networks. The company  announced the FDA clearance of its e-ASPECTS module in March 2023, its flagship software that is powered by patented, explainable AI to assess non-contrast CT scans to automatically generate an ASPECTS score and features a unique overlaid heatmap that enables a more nuanced assessment of each region.

Dr Michalis Papadakis, added, “As a spin-out from the University of Oxford, we have a longstanding heritage of scientific and academic excellence, which has allowed us to achieve broad success in the UK and across Europe, including national-level deployments of Brainomix 360 across Hungary and Wales, as well as wide-ranging roll-outs in England, Poland, Sweden, Italy and Spain.”

With deployments across more than 30 countries, Brainomix’s AI stroke software has been studied and validated in more than 60 publications, including a set of recent studies showing that the implementation of Brainomix software enabled faster treatment by reducing door-in-door-out times by more than one hour, and improved patient outcomes by tripling the number of patients achieving functional independence after stroke,1 while also increasing the rates of both thrombolysis and thrombectomy by more than 50%.2


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