Cumulus Neuroscience announced on May 4, 2023, that its dry-sensor electroencephalograph (EEG) headset has received FDA 510(k) clearance. The device is FDA-cleared for use in adults and adolescents for the remote acquisition, display and storage of EEG data.
About the Cumulus EEG headset
The Cumulus EEG device is designed for self-directed use at home or in a health care facility. It is used for the acquisition of physiological signals using two or more channels of EEG from the scalp.
The system consists of the EEG headset, a mobile device with mobile app software, earphones and charging cord. According to the company’s press release, it is self-applied in less than five minutes with guidance from the mobile app.
This technology allows health care professionals to review EEG recordings in real time. According to the FDA approval letter, it is available by prescription only.
Read more industry news from the AASM.
