Cumulus Neuroscience has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its dry-sensor electroencephalograph (EEG) headset.
The approval marks the second medical device authorisation received for the Cumulus EEG headset. Earlier, the device secured the UK Conformity Assessed marking in the UK.
The Cumulus EEG device has been developed for self-directed use in a home or clinical setting.
With the latest approval, it can be used by adult and adolescent patients for obtaining, displaying and storing EEG data remotely.
Currently available in four sizes, the device can be applied by users within five minutes using the Cumulus mobile app.
It can be operated without the requirement of support from an EEG technician or healthcare professional.
The headset offers a way to conduct clinical trials remotely by transmitting data to the Cumulus Medical Device Hub, thereby enabling real-time evaluation of EEG recordings by healthcare professionals.
Cumulus Neuroscience chief scientific officer Brian Murphy said: “Receiving 510(k) clearance from the FDA marks a major milestone for Cumulus and for our biopharma innovator partners in the US and Europe who need the ability to capture clinical-grade EEG signals from patients while at-home to accelerate their development programmes for precision CNS medicines.”
In addition, Cumulus announced the appointment of Tina Sampath as its new chief commercial officer.
Sampath will be responsible for promoting commercial growth as well as supervising strategic collaborations, marketing and corporate communications at the company.
Cumulus Neuroscience CEO Aman Bhatti said: “Becoming FDA-cleared is another gratifying leap forward for Cumulus, as we work to become the preferred precision CNS drug development partner for biopharma innovators and advance the possibilities for new treatments for neuropsychological disorders.”