FDA Radiology AI Devices

The Dreem 3S is a wearable headband device that uses EEG electrodes and a 3D accelerometer to record brain electrical activity and movement during sleep. It applies an artificial neural network to automatically analyze and classify sleep stages, providing clinicians with detailed reports of patients' sleep patterns to aid in sleep assessment at home or in healthcare settings.

NeuroRPM is a software application for the Apple Watch that uses machine learning to analyze motion sensor data to quantify motor symptoms like tremor, bradykinesia, and dyskinesia in adult Parkinson's disease patients. It helps clinicians remotely monitor symptom presence every 15 minutes, supporting both clinic and home use for improved patient management.

SomnoMetry, developed by Neumetry Medical Inc, is an AI-powered software that helps clinicians analyze sleep studies by automatically scoring physiological signals from polysomnography tests. It aids in diagnosing sleep quality and respiratory sleep disorders such as obstructive apnea, facilitating more efficient and accurate sleep study evaluations under clinical supervision.

EYE-SYNC is a portable eye-tracking device that helps medical professionals diagnose concussions by recording and analyzing eye movements. It includes a head-mounted eye tracker, a display, and a tablet app that together monitor eye motion patterns to detect impairments linked to mild traumatic brain injury in sports-related head injuries. This assists healthcare providers in making timely and accurate concussion assessments.

The EyeBOX is an eye-tracking device designed to assist clinicians in diagnosing concussion by analyzing eye movements. Patients watch a video on a screen while a near-infrared camera records their eye gaze data. The device processes this data using advanced algorithms to detect subtle abnormalities in eye movement that indicate concussion, helping doctors make timely and accurate assessments.

BrainScope TBI is a portable, non-invasive device that assists clinicians in evaluating patients with mild traumatic brain injury and concussion by analyzing brain electrical activity through EEG along with cognitive tests and clinical symptoms. It helps identify the likelihood of structural brain injury and assesses brain function, supporting decisions about the need for further imaging like CT scans.

EyeBOX is an eye-tracking device designed to help diagnose concussion by measuring and analyzing eye movements in patients within one week of a head injury. It uses near-infrared cameras to track gaze positions and an AI-driven algorithm to detect subtle changes in eye movements associated with concussion, aiding clinicians in neurological assessment.

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.

The Ahead 300 is a portable, non-invasive medical device that records and analyzes brain electrical activity to assist clinicians in evaluating patients with closed head injuries. It provides algorithm-based classifications of structural brain injury and measures brain function and cognitive performance to support diagnosis and treatment decisions, particularly to aid in deciding on the necessity of head CT scans.

The BrainScope Ahead 200 is a portable EEG device designed to aid physicians in evaluating patients with mild traumatic brain injury by measuring and analyzing brain electrical activity. It supports clinical decision-making regarding the need for head CT scans by providing objective quantitative EEG parameters. The device is intended for use as an adjunct to standard clinical practice and includes features such as continuous impedance monitoring and cognitive assessment tools for military use. It helps clinicians by providing rapid brain activity data to support the assessment of brain injury severity without replacing imaging such as CT scans.