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Cutting-edge Stroke AI Technology gets FDA Clearance



Oxford based Brainomix have announced they have received FDA clearance for its flagship stroke artificial intelligence imaging software.

This means that its Brainomix 360 e-ASPECTS tool for stroke can now be deployed for use in US stroke centres.

The Brainomix 360 stroke platform is a collection of tools that use state-of-the-art AI algorithms to support doctors by providing real-time interpretation of brain scans to help guide treatment and transfer decisions for stroke patients, thus allowing them to be treated in the right place, at the right time.  

The Brainomix 360 e-ASPECTS tool, powered by explainable AI, assesses non-contrast CT scans in order to automatically generate ASPECTS score and also features a unique overlaid heat map to visually assist clinicians to assess the output.

ASPECTS, is a globally recognised quantitive scoring system created by Brainomix co-founder and Professor of Stroke Medicine at the University of Oxford, Alastair Buchan, is used to measure the extent of early ischaemic changes and cited as a key selection criterion for endovascular treatment in all major stroke guidelines.

Newly published clinical trails have elevated the role of ASPECTS in helping to determine the best course of treatment for a now expanded group of eligible stroke patients.

Professor Raul G. Nogueria, Director of the University of Pittsburgh Medical Centre (UPMC) Stroke Institute, says: “This is a very exciting technology. For several years, I have had the pleasure of working as a consultant with Brainomix, who are driven by a philosophy of maximising the clinical value of simple imaging, accessible in all stroke centres.

“Brainomix has generated an impressive breadth of evidence and validation data for its e-ASPECTS tool.”

Recent studies have shown that the implementation of Brainomix software enable 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, whilst also increasing the rates of both thrombolysis and thrombectomy by more than 50 per cent.

Dr Michalis Papadakis, CEO and Co-Founder of Brainomix, says: “We are delighted to have the opportunity to now take our technology to the US, where more than 800,000 patients suffer a stroke each year.

“Our e-ASPECTS tool has been shown, in multiple countries and healthcare systems, to improve physicians’ interpretations of ASPECTS scores on non-contrast CT scans – which carries particular clinical value for primary stroke centres, where there may not be around-the-clock specialist expertise, but where most stroke patients are first admitted. Our technology supports these physicians who are making time-sensitive, critical decisions around transfer and treatment, strengthening networks and facilitating an improved stroke service.”

Brainomix has already established a US field team that will introduce the Brainomix 360 platform to stroke centres across the country and provide dedicated ongoing support.