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FDA authorizes the first AI-driven MRI solution for safer Alzheimer's treatment

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Nov 14, 2024, 5:00 AM ET

BOSTON and LEUVEN, Belgium, Nov. 14, 2024 /PRNewswire/ -- Why this news will impact the lives of people affected by Alzheimer's disease:

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

On November 7^th 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.

"Amyloid-lowering treatments represent an important
advance in the treatment of Alzheimer's disease but
they are associated with a risk of brain swelling and
hemorrhage called ARIA. New standardized tools are
needed, such as icobrain aria, to assist radiologists and
treating clinicians in detecting and managing ARIA to
optimize patient safety.

I am excited that icobrain aria has received FDA
approval, clearing the way for wider use in clinical
practice."

Prof. Stephen Salloway
Butler Hospital and
Professor of Neurology and P
sychiatry at the Warren
Alpert Medical School of
Brown University in
Providence, Rhode Island

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.

However, these promising drugs also carry risks, one of which is the development of ARIA (amyloid-related imaging abnormalities), a complication that can cause lesions in the brain, including edema, swelling and/or hemorrhages. According to the FDA, the prescription of these amyloid-targeting therapies requires intensive ARIA monitoring with repeated magnetic resonance imaging (MRI) brain scans to detect and assess these changes before they pose serious neurological risks. Until now, identifying and evaluating ARIA has been a labor-intensive process, involving detailed, time-consuming, and visual comparisons of the brain MRI scans by radiologists.

FDA nod for AI software to ensure patient safety

icobrain aria is a unique deep-learning-based AI solution that was trained on thousands of brain MRI scans to accurately detect, diagnose, and monitor ARIA and its severity. The software works in the background and automatically generates an overview report on the ARIA assessment for radiologists using normal clinical MRI scans.

"icobrain aria was thoroughly evaluated in large reader
studies. It was demonstrated that the assistance of AI
significantly improved radiologists' ability to detect and
classify ARIA, boosting both diagnostic sensitivity and
accuracy, and adding a critical safety option for patients
undergoing amyloid-targeting therapies."

Prof. Jeffrey Cummings
Director of the Chambers-
Grundy Center for
Transformative Neuroscience
at University of Nevada, Las
Vegas

"We are thrilled to announce FDA authorization of the first-
ever computer-aided detection and diagnosis solution in
neuroradiology. The FDA holds devices in this category to
exceptionally high standards of evidence and performance,
and this approval reflects the strong evidence behind
icobrain aria's ability to help radiologists assess important
safety events that can impact treatment and patient care."

Dr. Dirk Smeets
CTO icometrix

Impacting care for people with Alzheimer's disease

This FDA clearance is a big step forward in Alzheimer's care, demonstrating how technology can help bring safe and effective treatments to more people. With icobrain aria, physicians now have a powerful tool that helps them make informed treatment decisions, ensuring that patients receive the right care at the right time. This is a clear example of how advanced technology can make a difference in healthcare, supporting doctors and making important new therapies more widely accessible.

"For families facing Alzheimer's disease, the new disease-
modifying therapies have brought renewed hope.

But to help as many people as possible, we do need to
standardize care pathways and make sure we have access
to cognitive tests, blood biomarkers, and imaging exams
that can ensure a timely diagnosis and a safe drug
prescription.

Thanks to the FDA clearance of icobrain aria, Alzheimer's
therapies are more accessible and safer for patients, as it
provides clinicians with the tools they need to make
informed, effective treatment decisions."

George Vradenburg
Chairman of
UsAgainstAlzheimer's

About icometrix

icometrix is a global leader in AI-driven software for brain imaging, transforming MRI and CT scans into actionable data for neurological conditions such as Alzheimer's, multiple sclerosis, and Parkinson's disease. Used in over 300 hospitals worldwide, icobrain technology is setting new standards in precision brain health, supporting doctors with tools that are FDA-cleared in the U.S. and approved in regions across the globe. With a commitment to advancing safe, effective treatments, icometrix partners with top pharmaceutical and health tech companies to bring innovative solutions to those who need them most.

Media Contact: marketing@icometrix.com or
CEO and CTO
Wim Van Hecke - CEO
wim.vanhecke@icometrix.com
+32 484 92 73 00