Cumulus Neuroscience EEG Headset Cleared for At-Home Use

Cumulus Neuroscience has received 510(k) clearance from the FDA for its Cumulus EEG dry-sensor electroencephalograph (EEG) headset, allowing healthcare professionals to remotely monitor test readings in real time.

The device can be used by adult and adolescent patients for the remote acquisition, display and storage of EEG data and can be self-applied with guidance from the mobile app at the patient’s home or a healthcare facility.

"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,” the company said.

This clearance is the second for the headset, which previously received the UK Conformity Assessed (UKCA) mark in the United Kingdom.

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