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Alzheimer's Association International Conference 2026

July 12-15, 2026 | London, United Kingdom, and Online

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5147

Clinical Readiness Of Automated Cerebral Microbleed Detection: A Technology Readiness Level Evaluation

Part of Topic

Background: 

Amyloid-targeting treatments require MRI-based safety monitoring for amyloid-related imaging abnormalities (ARIA), including cerebral microbleeds (CMB).

 

Visual CMB detection is prone to low inter-reader agreement and is a time-consuming task.

 

Automated CMB detection systems are getting regulatory approval for ARIA monitoring, but little is known about the clinical impact of this emerging technology.

 

aim:

To what extent have automated cerebral microbleed detection systems achieved technological readiness, and how have they been validated?

 Methods:

A systematic search was conducted in Embase, Web of Science, and MEDLINE on January 9, 2026.

•Strategy: Broad search capturing variations in naming (e.g., “hemorrhage”) and clinical contexts like ARIA and Cerebral Small Vessel Disease.
•Screening: 7,674 studies screened.
•Exclusion: Non-MRI modalities and studies in which the microbleed tool was not evaluated on its own.
•Inclusion: 68 studies met inclusion criteria.

 

Studies were evaluated using the technology readiness level (TRL) framework adapted by Fleuren (2020) for clinical applications1.

 

Data was systematically extracted using a template covering:

•MRI acquisition
•Ground truth establishment
•Outcomes assessed
•Validation method and performance stratification
•Number of clinicians involved

 

Bias was assessed using PROBAST-AI.

 

TRL results:

•Automated CMB detection systems were primarily validated on technical performance (TRL ≤ 5).
•Reader studies focused primarily on task-related outcomes, such as detection accuracy and reading time. Typically, these included few readers (median = 2.5, range = 1-16)
•A single study assessed how automated CMB detection affects a high-level clinical task (ARIA grading).
•No post-market evaluations of implemented systems have been published.
•Over time no trend towards higher TRL was observed, suggesting a structural barrier.
 

Gaps:

Technical robustness:

CMB appearance varies by MRI acquisition (Patient with cerebral amyloid angiopathy scanned at 1.5 T using T2* (A) and SWI (B).

 

Gap: Most detection systems are developed on homogeneous datasets.

Risk: Differences in MRI acquisition alter CMB appearance, reducing reliability across sites and over longitudinal follow-up.

Action: Assess performance across diverse MRI scanners, acquisition protocols, and repeated examinations.

 

Algorithmic Fairness: 

CMB spatial distribution varies by etiology (A: cerebral amyloid angiopathy, B: Hypertension.

 

Gap: Limited evidence suggests non-uniform performance across the brain.

Risk: Automated detection systems may be biased towards specific presentations.

Action: Stratify performance by anatomical regions and clinical/demographic groups to uncover algorithmic bias.

 

Clinical intergation:

User Diversity

Gap: We do not know if all clinicians benefit from automated CMB detection equally.

Risk: Inexperienced readers may unsafely over-rely on false positives or negatives.

Action: Include diverse readers (e.g., experience, specialty) to assess who benefits.

Post-market Evaluation

Gap: Zero studies have tracked long-term software impacts in actual clinics.

Risk: Hospitals risk adopting expensive tools that may fail to improve safety, speed, or costs.

Action: Evaluate post-market patient outcomes, workflow speeds, and cost-effectiveness.

 
Take home message:
Automated CMB detection systems are stuck in technical validation. To achieve clinical readiness, future research must prioritize imaging robustness, algorithmic fairness, longitudinal tracking,

and real-world utility.

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