FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

BrainSee is software that helps clinicians predict whether patients aged 55 to 95 with amnestic mild cognitive impairment (aMCI) will progress to clinical Alzheimer's disease dementia within 5 years. It uses standard brain MRI scans along with patient demographics and cognitive test scores to generate a similarity score indicating the likelihood of progression. This tool provides supplemental prognostic information to aid clinical decision-making but is not a standalone diagnostic device.

Product Code
QWT

EyeBOX is a device that uses an eye-tracking camera and software to measure and analyze eye movements as an aid in assessing concussion within one week of head injury for patients aged 5 to 67. It provides clinicians with a score indicating possible brain injury based on abnormal eye movement patterns, helping supplement traditional neurological assessment.

Product Code
QEA

The BrainScope Ahead 100 is a portable EEG-based device designed to assist physicians in evaluating patients with mild traumatic brain injury. It analyzes brain electrical activity to help decide if a head CT scan is needed, potentially reducing unnecessary CT scans and radiation exposure. The device processes EEG data using AI-driven algorithms to classify patients based on the likelihood of structural brain injury visible on CT.

Product Code
PIW
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