FDA Radiology AI Devices

The Dreem 3S is a wearable headband device that records brain electrical activity (EEG) and movement data during sleep. It uses AI algorithms based on neural networks to automatically analyze this data and produce detailed sleep stage reports for adults. This helps clinicians assess sleep patterns and disturbances remotely in home or healthcare environments.

The Cerebral Autoregulation Index (CAI) Algorithm is a software tool designed to help clinicians monitor whether cerebral autoregulation—the brain's ability to maintain stable blood flow—is intact or impaired. It analyzes signals from cerebral oximetry and blood pressure monitors to provide an index value indicating the level of coherence between these parameters. This helps guide advanced hemodynamic monitoring in critical care patients without making direct therapeutic decisions.

SleepStageML is a software-only medical device that uses AI to automatically analyze EEG signals from sleep studies (PSG recordings) to identify different sleep stages. It assists qualified clinicians in diagnosing sleep quality and sleep disorders in adult patients by providing automated, software-generated sleep stage annotations that clinicians can review and verify.

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.

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.