FDA grants 510(k) clearance for self-directed EEG headset

The FDA has granted 510(k) clearance to Cumulus Neuroscience for its dry-sensor electroencephalogram headset, for self-directed use by adolescents and adults at home or at health care facilities.

According to a release from Cumulus, the headset — which previously received the UK Conformity Assessed (UKCA) mark — is available in four sizes and can be fitted by the patient in less than 5 minutes with guidance from the company’s mobile app. The device’s integrative technology enables data to be transmitted remotely and directly to the Cumulus Medical Device Hub, allowing for real-time EEG evaluation by health care professionals.

“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,” Brian Murphy, Cumulus founder and chief scientific officer, said in the release.