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The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep and awake in the home or healthcare environment. The Dreem 3S can also output a hypnogram of sleep scoring by 30-second epoch and summary of sleep metrics derived from this hypnogram. The Dreem 3S is used for the assessment of sleep on adult individuals (22 to 65 years old). The Dreem 3S allows for the generation of user/predefined reports based on the subject's data.

The Dreem 3S headband contains microelectronics, within a flexible case made of plastic, foam, and fabric. It includes 6 EEG electrodes and a 3D accelerometer sensor. The EEG signal is measured by two electrodes in the frontal position) and two at the back of the head (occipital position), along with one reference electrode and one ground electrode. The 3D accelerometer is embedded in the top of the headband to ensure accurate measurements of the wearer's head movement during the night. The raw EEG and accelerometer data are transferred to Dreem's servers for further analysis after the night is over. The device includes a bone-conduction speaker with volume control to provide notifications to the wearer, and a power button circled by a multicolor LED light The device generates a sleep report that includes a sleep staging for each 30-second epoch during the night. This output is produced using an algorithm that analyzes data from the headband EEG and accelerometer sensors. A raw data file is also available in EDF format.

SleepStageML is intended for assisting the diagnostic evaluation by a qualified clinician to assess sleep quality from level 1 polysomnography (PSG) recordings in a clinical environment in patients aged 18 and older. SleepStageML is a software-only medical device to be used to analyze physiological signals and automatically score sleep stages. All outputs are subject to review by a qualified clinician.

SleepStageML is an Artificial Intelligence/Machine Learning (Al/ML)-enabled software-only medical device that analyzes polysomnography (PSG) recordings and automatically scores sleep stages. It is intended for assisting the diagnostic evaluation by a qualified clinician to assess sleep quality in patients aged 18 and older. Qualified clinicians (also referred to as clinical users) such as sleep physicians, sleep technicians, or registered PSG technologists (RPSGTs) who are qualified to review PSG studies, provide PSG recordings in European Data Format (EDF) file format through a secure file transfer system to Beacon Biosignals. SleepStageML automatically analyzes the provided PSG recording and return an EDF file containing the original PSG recording with software-generated sleep stage annotations (i.e., Wake (W), non-REM 1 (N1), non-REM 2 (N2), non-REM 3 (N3), and REM (R)) back to the clinical user. The EDF files containing PSG signals as well as sleep stage annotations are referred to as EDF+. The returned EDF+ files can then be reviewed by the qualified clinicians via the users' PSG viewing software. The recordings processed by SleepStageML are level-1 PSG recordings obtained in an attended setting in accordance with American Association of Sleep Medicine (AASM) recommendations with respect to minimum sampling rate, electroencephalography (EEG) channels, and EEG locations. SleepStageML only uses the EEG signals in provided PSGs and does not consider electromyography (EMG) or electrooculography (EOG) signals when performing sleep staging. The sleep stage outputs of SleepStageML are intended to be comparable to sleep stages as defined by AASM guidelines. SleepStageML software outputs are subject to qualified clinician's review.

The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep and awake in the home or healthcare environment. The Dreem 3S can also output a hypnogram of sleep scoring by 30-second epoch and summary of sleep metrics derived from this hypnogram. The Dreem 3S is used for the assessment of sleep on adult individuals (22 to 65 years old). The Dreem 3S allows for the generation of user/predefined reports based on the subject's data.

The Dreem 3S headband contains microelectronics, within a flexible case made of plastic, foam, and fabric. It includes 6 EEG electrodes and a 3D accelerometer sensor. The EEG signal is measured by two electrodes in the frontal position) and two at the back of the head (occipital position), along with one reference electrode and one ground electrode. The 3D accelerometer is embedded in the top of the headband to ensure accurate measurements of the wearer's head movement during the night. The raw EEG and accelerometer data are transferred to Dreem's servers for further analysis after the night is over. The device includes a bone-conduction speaker with volume control to provide notifications to the wearer, and a power button circled by a multicolor LED light The device generates a sleep report that includes a sleep staging for each 30-second epoch during the night. This output is produced using an algorithm that analyzes data from the headband EEG and accelerometer sensors. A raw data file is also available in EDF format. The algorithm uses raw EEG data and accelerometer data to provide automatic sleep staging according to the AASM classification. The algorithm is implemented with an artificial neural network. Frequency spectrums are computed from raw data and then passed to several neural network layers including recurrent layers and attention layers. The algorithm outputs prediction for several epochs of 30 seconds at the same time, every 30 seconds. The various outputs for a single epoch of 30 seconds are combined to provide robust sleep scoring.