FDA-Cleared AI Device

icobrain

icometrix

Automated quantification of brain structure volumes and white matter lesion load from MRI, with reports comparing a patient against normative reference data.

At A Glance

Manufacturer
icometrix
Medical specialty
Neurology
Clearance route
510(k)
Year authorized
2016 onward
Modality
Brain MRI and CT
Role in workflow
Quantification

Brain atrophy is a good example of a finding humans read poorly. Radiologists describe volume loss qualitatively and inconsistently, and small year-over-year changes matter clinically while sitting well below what visual inspection can detect. Quantification is not competing with expert reading here. It is measuring something that was not being measured.

Where It Is Used

  • Multiple sclerosis lesion and atrophy tracking
  • Dementia workup volumetric assessment
  • Traumatic brain injury quantification

Limitations Worth Knowing

Volumetric output is highly sensitive to acquisition parameters, and comparing scans across scanners or protocols can produce apparent change that is entirely technical. Normative databases may not represent the patient's demographic, which shifts percentile-based interpretation.

Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.

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