Implant Type
EEG
Electrodes
4
Channels
4
FDA Status
de-novo
Status
commercial
About
The Muse S is InteraXon's sleep-focused consumer EEG headband, featuring the same 4 EEG channels as Muse 2 (AF7, AF8, TP9, TP10) in a soft, flexible fabric form factor with silver-thread sensors designed for overnight wear. Streams raw EEG data at 256 Hz via Bluetooth for real-time biofeedback for meditation and sleep stage tracking. Includes PPG heart rate monitoring and accelerometer. The Muse platform has been used in over 200 peer-reviewed neuroscience studies. FDA De Novo clearance received for digital health use.
Target Conditions
insomniastressmeditation trainingsleep quality
Milestones
2014-03Original Muse headband launched at SXSW
2019-11Muse S sleep-focused headband released
2021-09Muse S Gen 2 with enhanced sensors launched
FDA Regulatory Pathway
No FDA Regulatory Status
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 ↗