Oxford’s Brainomix gets FDA clearance for stroke AI imaging software

Brainomix, an Oxford-based AI powered med-tech solutions company, has revealed that its 360 e-ASPECTS tool for stroke imaging has received FDA clearance.

This announcement means that the company is now able to deploy its stroke AI imaging platform to US stroke centres. The company has already deployed the 360 e-ASPECTS tool in 30 countries following the product receiving validation from over 60 academic papers.

The Brainomix 360 stroke platform is a collection of tools that use AI algorithms to support doctors by providing real-time interpretation of brain scans to help guide treatment and transfer decisions for stroke patients.

Director of the University of Pittsburgh Medical Centre Stroke Institute Prof Raul G. Nogueira said: “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 maximizing 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.”

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e-ASPECTS was created by Brainomix co-founder and Professor of Stroke Medicine at the University of Oxford, Alastair Buchan. The tool is used to measure the extent of early ischemic changes and cited as a key selection criterion for endovascular treatment in all major stroke guidelines.

Recent studies have indicated that use of Brainomix software reduced door-in-door-out times at Stroke centres by over an hour. Furthering this, the number of patients that achieve functional independence following a stroke tripled following the implementation of Brainomix software.

CEO and co-founder of Brainomix Dr Michalis Papadakis said: “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.’’

Brainomix has an established US field team that will introduce the Brainomix 360 platform to stroke centres across the country. The company also recently announced a partnership with Blackford, an imaging AI platform and solutions provider, who will distribute e-ASPECTS across its network.

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