FDA Clears Automated ASPECTS Scoring from CT 

A neuroimaging analysis device (Rapid Aspects; RapidAI, Menlo Park, CA) has received Food and Drug Administration (FDA) clearance, the first such device to obtain clearance in the computer-assisted diagnostic software (CADx) category.  

The device can assist in physicians’ interpretations of noncontrast CT using a standardized Alberta Stroke Program Early CT Scoring (ASPECTS) score. The automated score from the device, combined with the physician’s review of the scan, can improve the accuracy of ASPECTS score calculation. 

The device uses a machine-learning algorithm to identify the ASPECTS regions of the brain and generate an ASPECTS score to show early signs of brain infarction on noncontrast CT. This information helps physicians identify areas of irreversible brain injury and determine a patient’s eligibility for thrombectomy.  

 “Rapid Aspects represent the next AI-powered step forward in stroke imaging, and the groundbreaking CADx clearance from the FDA puts it in a class by itself,” said Greg Albers, MD, professor of neurology, Stanford University, director of the Stanford Stroke Center, and cofounder of RapidAI. “In addition to helping stroke teams with faster triage and transfer decisions, Rapid Aspects also improves the accuracy of typical readers.”