The Muse S is InteraXon's sleep-focused consumer EEG headband, featuring 7 sensors (4 active EEG channels at Fp1, Fp2, TP9, TP10) in a soft, flexible form factor designed for overnight wear. The device streams raw EEG data at 256 Hz via Bluetooth to the companion Muse app, which provides real-time biofeedback for meditation and sleep stage tracking. The Gen 2 model adds PPG heart rate monitoring and a 3-axis accelerometer. The Muse platform has been used in over 200 peer-reviewed neuroscience studies and received FDA De Novo clearance for digital health use.
This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.
FDA Device Regulatory Guidance ↗