A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device; 510(k) clearance from the FDA allows for Cumulus’ dry-sensor EEG headset to be legally marketed in the U.S.
The digital health gained its clearance for its dry-sensor electroencephalograph (EEG) headset that can now be used for adult and adolescent patients, at home with self-directed use for the storage of EEG data.
This represents the second medical device clearance for the headset, which had already received the UK Conformity Assessed (UKCA) mark in the UK.
The headset is easily self-applied in less than five minutes with guidance from the Cumulus mobile app – eliminating the need for EEG technician or healthcare professional support. The technology, the company says, provides a means to initiate clinical studies remotely with data transmitted to the Cumulus Medical Device Hub, allowing healthcare professionals to review EEG recordings in real-time.
Brian Murphy, founder and chief scientific officer, Cumulus Neuroscience, 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 central nervous system (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.”
Aman Bhatti, CEO at Cumulus, 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 decentralized 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.”
Cumulus supports precision in CNS clinical trials for its industry partners by enabling remote monitoring of patients across multiple domains of brain function.
It says its mission is to generate the data and insights required to accelerate diagnosis and management of central nervous system (CNS) disorders for patients and caregivers around the world. Cumulus Neuroscience says it is advancing an AI-based, multi-domain digital biomarker platform to enable better, faster decision making in neurology and neuropsychiatry clinical trials and patient care.
Cumulus said it designs for and with 10 of the world's leading pharma companies, the platform enables decentralized trials, and says it is already making a difference in the development of therapies for Alzheimer's Disease, depression and schizophrenia.