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 slow adoption of Alzheimer’s treatments amid safety concerns
The FDA’s nod for icobrain aria comes at a time when much-needed new Alzheimer’s treatments are reshaping care options in the United States. The first breakthrough in Alzheimer’s disease treatment was in 2021 when aducanumab (Aduhelm) became the first FDA-approved drug intended to slow Alzheimer’s progression by reducing amyloid plaques in the brain. This breakthrough, making headlines worldwide, was followed by other therapies, including lecanemab (Leqembi) and donanemab (Kisunla), each designed to target amyloid buildup, which is believed to play a role in Alzheimer’s disease. Together, these treatments represent a shift from symptom management to disease-modifying approaches, offering hope to millions of patients and their families