AI Software to Assist with Stroke Assessment Receives FDA Clearance

A computer-assisted diagnostic software device (Brainomix 360 e-ASPECTS; Brainomix, Oxford, UK) has received clearance by the Food and Drug Administration (FDA) to assist clinicians in assessing and categorizing abnormal non-contrast CT scans of the brain. This software device, which is cleared for use in patients with middle cerebral artery or internal carotid artery occlusion, analyzes CT image data with artificial intelligence software to produce a single ASPECTS (Alberta Stroke Program Early CT Score) score which can be modified by a clinician, if needed. The device also extracts individual voxel data from images to create a “heat map” of hypodense regions to assist with clinical assessment of ischemic brain tissue injury. According to the 510(k) summary of safety and effectiveness, use of the Brainomix 360 e-ASPECTS device provides a comparative analysis to traditional standard of care radiologic assessment using ASPECTS.

A number of limitations to use of the device are noted in the clearance documents:

• The device has only been validated and is cleared for use in patients aged >21 years.
• The e-ASPECTS tool is intended for use with Siemens SOMATON Definition scanners.
•  The device should not be used as a primary diagnostic tool.
• Mobile images are not suitable for analysis.
• Physicians should not use the software device for other conditions, such as hemorrhagic events and hematomas.

Providers should not use the Brainomix 360 e-ASPECTS device in patients who are unable to sit still for the scan, as it may cause artifacts on the image. While there are minimal risks associated with this device, incorrect scoring could result in false negatives.

According to 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.”

The e-ASPECTS tool has already been approved in 30 different countries. This software will be used in stroke centers throughout the United States to assist physicians in making time-sensitive treatment decisions.