FDA Radiology AI Devices

The REMI AI Discrete Detection Module (REMI-AI DDM) is a software tool designed to assist physicians qualified in EEG interpretation by automatically identifying and marking sections of EEG recordings that may correspond to seizure-like events. It processes previously acquired EEG data collected via the REMI Remote EEG Monitoring System, helping speed up and improve the review process for EEG data in patients aged 6 years and older. The software does not provide diagnostic conclusions but serves as an aid to clinicians in seizure detection support.

Alignment System Cranial by Brainlab AG is a surgical navigation system designed to assist surgeons during cranial stereotactic procedures such as biopsies of intracranial lesions and placement of stereo-electroencephalography electrodes. It integrates optical tracking with advanced software and hardware to precisely guide surgical instruments, improving accuracy and safety. The system includes artificial intelligence features that aid in patient registration processes by detecting anatomical landmarks, enhancing surgical planning and execution.

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.

The Cranial Navigation and Cranial EM System by Brainlab AG is an image-guided surgical navigation system designed to assist surgeons during cranial and craniofacial procedures. It uses imaging data like CT, MR, X-Ray, and ultrasound to track surgical instruments relative to patient anatomy. The system integrates artificial intelligence via machine learning algorithms to detect brain abnormalities and anatomical landmarks in MR images to enhance registration accuracy and view centering, helping surgeons perform more precise navigation in complex brain surgeries.

The Ceribell Status Epilepticus Monitor is a software medical device that analyzes EEG data captured from a headband device to automatically detect electrographic status epilepticus in patients at risk of seizures. It provides timely diagnostic support to clinicians in acute care environments, enabling faster treatment decisions for this critical neurological condition.

Brainlab Elements Trajectory Planning (2.6) is a software designed to help neurosurgeons plan the best paths for surgical instruments during cranial procedures, such as electrode placements or biopsies. It uses anatomical images from scans to plan and guide minimally invasive or open surgeries, enhancing precision and improving patient outcomes.

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.

EnsoSleep is a software medical device designed to analyze previously recorded physiological signals from sleep studies to automatically score sleep stages, detect arousals, leg movements, and various types of sleep-disordered breathing events. It supports both adult and pediatric patients and can be used for in-lab or home sleep tests. EnsoSleep assists clinicians by providing automated detection and scoring of events, which are then verified and can be edited by qualified clinicians to aid in diagnosing sleep disorders.