Brainomix receives US FDA clearance for flagship stroke AI imaging software

360 e-ASPECTS tool (Copyright: Brainomix)

Brainomix has today announced that its 360 e-ASPECTS tool for stroke has received US Food and Drug Administration (FDA) clearance, enabling the company to deploy its cutting-edge artificial intelligence (AI) imaging platform to stroke centres in the USA.

With deployments across more than 30 countries, Brainomix’s AI stroke software has been studied and validated in over 60 publications, a press release notes. 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, helping to guide treatment and transfer decisions for stroke patients, and allowing patients to be treated in the right place at the right time.

Powered by explainable AI, the Brainomix 360 e-ASPECTS tool assesses non-contrast computed tomography (CT) scans to automatically generate an Alberta stroke programme early CT (ASPECT) score and features a unique overlaid heatmap to visually assist clinicians in assessing the output.

“This is a very exciting technology,” noted Raul Nogueira (University of Pittsburgh Medical Center Stroke Institute, Pittsburgh, USA). “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.”

According to the company, recent studies have shown 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, while also increasing the rates of both thrombolysis and thrombectomy by more than 50%.

“We are delighted to have the opportunity to now take our technology to the USA, where more than 800,000 patients suffer a stroke each year,” said Michalis Papadakis, CEO and co-founder of Brainomix. “Our e-ASPECTS tool has been shown, in multiple countries and healthcare systems, to improve physicians’ interpretations of ASPECT 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 an established US field team that will introduce the Brainomix 360 platform to stroke centres across the country and provide dedicated ongoing support, a company press release also details.


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