FDA Radiology AI Devices

NEAT 001 is a software medical device that automatically analyzes EEG data obtained during sleep studies to detect different stages of sleep according to established sleep medicine guidelines. It helps clinicians by providing automated scoring and visualization of sleep stages, improving the efficiency and consistency of sleep evaluations in adult patients.

DeepRESP is a cloud-based AI software tool that analyzes sleep study recordings, with or without EEG signals, to assist clinicians in diagnosing sleep disorders. It automatically marks events, calculates parameters like the Apnea-Hypopnea Index, and infers sleep stages. This helps medical professionals to efficiently assess sleep health and tailor treatments.

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.

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.

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.

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.