Cumulus Neuroscience, a digital health company focused on neuroscience, has received the US Food and Drug Administration (FDA) 510(k) approval for its novel dry-sensor EEG headset.

The device is the company’s second medical device headset to receive regulatory approval, after the UK Conformity Assessed (UKCA) mark in the UK.

The Cumulus EEG device is indicated for the remote acquisition, display, and storage of electroencephalograph (EEG) data by adults and adolescents.

It is designed for self-directed use in a patient’s home or a healthcare facility, eliminating the need for EEG technicians or healthcare professional support.

Offered in four sizes, the EEG device can be self-applied in less than five minutes with guidance from the Cumulus mobile app.

The advanced technology provides enables the researchers to begin clinical studies remotely with data transmitted to the Cumulus Medical Device Hub.

It also allows healthcare professionals to review EEG recordings in real-time.

Cumulus Neuroscience founder and 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 programs for precision CNS medicines.

“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.”

The FDA approval follows the appointment of Tina Sampath as Chief Commercial Officer (CCO), who has more than 23 years of experience in biopharma, diagnostic and med tech companies.

Cumulus Neuroscience is focused on generating the data and insights required to advance the diagnosis and management of central nervous system (CNS) disorders.

The company develops an AI-based, multi-domain digital biomarker platform that enabled quick decision-making in neurology and neuropsychiatry clinical trials and patient care.

The platform enables decentralised clinical trials and is already being used in the development of therapies for Alzheimer’s Disease, depression and schizophrenia.

Cumulus combines its patented technology, in-house expertise and key industry partnerships to capture large amounts of real-world, clinical data, using its neuro-assessment platform.

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.

“A user-friendly EEG device that patients can apply themselves at home opens significant doors for decentralised clinical trials and remote patient monitoring, and with that, the possibility of improved diversity in clinical research that can lead to better data and outcomes.

“The fact that FDA clearance coincides with our recent design awards and Tina joining our executive team is incredibly exciting, and positions Cumulus for significant growth as we pursue our mission of accelerating precision treatments for and diagnosis of CNS disorders.”