FDA Clears AI-Powered Stroke Imaging Tool for Non-Contrast CT

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Brainomix 360 e-ASPECTS software (Brainomix), which provides adjunctive artificial intelligence (AI) assessment of computed tomography (CT) scans of the brain and automated scoring with the Alberta Stroke Program Early CT score (ASPECTS) system.

As part of the Brainomix 360 stroke platform, which emphasizes real-time AI-enabled interpretation of brain imaging in stroke patients, the e-ASPECTS software provides enhanced heatmap visualization and automated ASPECTS scoring based on non-contrast CT scans, according to Brainomix.

The company said recent studies have demonstrated the stroke imaging platform’s ability to reduce door-in door-out times and reportedly triple the number of patients regaining functional independence after stroke.

“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 … ,” noted Michalis Papadakis, CEO and co-founder of Brainomix. “Our technology supports these physicians who are making time-sensitive, critical decisions around transfer and treatment, strengthening networks and facilitating an improved stroke service.”

(Editor’s note: For related content, see “Portable MRI System Gets FDA Nod for AI-Powered Brain Imaging Software” and “TeraRecon Launches AI-Driven Neuroimaging Platform.”)