On November 7th 2024, the U.S. Food and Drug Administration (FDA) granted icometrix clearance for icobrain aria, the first and only AI software approved for detecting, measuring and grading amyloid-related imaging abnormalities (ARIA), a potentially harmful side effect of new amyloid-targeting therapies. A large study, needed for FDA clearance, demonstrated that the use of icobrain aria significantly increases the accuracy of ARIA assessments by radiologists and hence allows for safer use of new amyloid-beta targeting therapies for Alzheimer’s disease patients.
The first disease-modifying therapies for Alzheimer’s disease have come to the market over the previous years – providing hope to the millions affected by Alzheimer’s disease.
These therapies have been linked to the development of specific brain abnormalities known as Amyloid-Related Imaging Abnormalities (ARIA), which, although rare, can lead to neurological complications.
Regular brain MRI scans are needed to assess ARIA, but the detection and severity scoring is complex and time-consuming.
The FDA authorizes icobrain aria as the first and only AI solution to detect, diagnose, and monitor ARIA for individuals with Alzheimer’s disease.
