Brainomix’s Flagship Stroke AI Imaging Software OK’ed

Brainomix, an artificial intelligence (AI)-powered medtech solutions firm, has gained U.S. Food and Drug Administration (FDA) clearance for its Brainomix 360 e-ASPECTS tool for stroke. The company can now deploy its stroke AI imaging platform to U.S. stroke centers.
 
Brainomix’s AI stroke software has deployed across over 30 countries and has been studied and validated in more than 60 publications. Brainomix 360 is a collection of tools using AI algorithms for real-time brain scan interpretation to help guide stroke patients’ treatment and transfer decisions. The tool assesses non-contrast CT scans to automatically generate an ASPECTS score and features an overlaid heatmap for visual assistance.
 
ASPECTS is a globally recognized quantitative scoring system created by Brainomix co-founder and University of Oxford professor of stroke medicine Alastair Buchan. It’s used to measure the extent of early ischemic changes and is cited as key selection criteria for endovascular treatment in major stroke guidelines.
 
“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 centers,” Prof. Raul G. Nogueira, Director of the University of Pittsburgh Medical Center (UPMC) Stroke Institute, told the press. “Brainomix has generated an impressive breadth of evidence and validation data for its e-ASPECTS tool.”
 
Recently published studies demonstrated that implementing Brainomix software enabled faster treatment by reducing door-in-door-out times by over an 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%.
 
“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,” said Dr. 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 ASPECTS scores on non-contrast CT scans – which carries particular clinical value for primary stroke centers, 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.”
 
Reference
¹ Nagaratnam et al. Int J Stroke. 2021;16:28-29