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# FDA Clears Cumulus EEG Headset
- URL: https://www.fdaweb.com/fda-clears-cumulus-eeg-headset/
- Published: 2023-05-09T12:00:00.000Z
- Updated: 2026-09-14T18:30:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154401

FDA has cleared a Cumulus Neuroscience 510(k) for its dry-sensor Cumulus EEG headset and its use for the remote acquisition, display, and storage of electroencephalograph (EEG) data. “The headset is available in four sizes and is easily self-applied in less than five minutes with guidance from the Cumulus mobile app – eliminating the need for EEG technician or healthcare professional support,” the company says.

The device technology allows central nervous system (CNS)-related clinical studies to be conducted remotely with data being transmitted to the Cumulus Medical Device Hub for healthcare professionals to access, Cumulus Neuroscience says. “By providing reliable data across multiple domains of brain function, from specific disease symptoms to functional neurophysiology, clinical researchers can accelerate the development of treatments for neuropsychiatric and neurodegenerative disorders – bringing hope to millions of patients and families navigating unmet needs in the CNS ecosystem,” it adds.