FDA Clears Dry-Sensor, At-Home EEG Headset

Brian Murphy

According to an announcement from Cumulus Neuroscience, the FDA has granted 510(k) clearance to its novel, dry-sensor EEG headset, a user-friendly device that enables self-directed use and generates clinical-grade data for remote physician review.

The Cumulus EEG device, designed for both adult and adolescent patients, is available in 4 sizes, and is easily self-applied in less than 5 minutes with guidance from the Cumulus mobile app, thus eliminating the need for EEG technician or healthcare professional support. The platform combines clinical-grade, at-home data with machine learning analytics and a large real-world database of annotated, longitudinal, matched data.

"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,” Brian Murphy, founder and chief scientific officer, Cumulus Neuroscience, said in a statement. “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."

In 2022, a study published in Frontiers in Digital Health tested Cumulus Neuroscience’s at-home EEG technology and gamified cognitive tasks in unsupervised older and younger adults. Two separate cohorts of participants­–50 older adults and 30 younger adults–had data collected at home over several weeks using the wireless dry EEG system interface with a tablet for task presentation. All participants were asked to complete gamified versions of a visual Oddball task and Flanker task 5-7 days per week.²

In total, the study comprised of 1449 EEG sessions from older adults and 684 sessions from younger adults. Both groups demonstrated high tolerance to the headset, as 93% of older adults completed requested sessions, reporting a mean usability score of 84.5, while 96% of younger adults successfully completed sessions, with a reported mean usability score of 88.3. Aggregation of event-related potential components across sessions (2-4, depending on task) resulted in grand average signal quality with similar standard measurement error values to those of single-session wet EEG data collected by experts in a laboratory setting from a young adult sample.

Overall, the data demonstrated that portable EEG technology using Cumulus’ headset was a suitable tool for cognitive neuroscience investigations, and has potential to provide objective, frequent, and patient-centered tracking of biomarkers of functional neurophysiology. Additionally, investigators concluded that this approach has potential to facilitate large-scale longitudinal studies of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders that manifest on different time scales.

"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," Aman Bhatti, MD, chief executive officer, Cumulus Neuroscience, said in a statement.¹ "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."

REFERENCES
1. Cumulus Neuroscience receives FDA 510(k) clearance for award-winning, first-in-class neurophysiology platform for at-home use. News release. May 4, 2023. Accessed May 4, 2023. https://www.prnewswire.com/news-releases/cumulus-neuroscience-receives-fda-510k-clearance-for-award-winning-first-in-class-neurophysiology-platform-for-at-home-use-301816234.html
2. Barbey FM, Farina FR, Buick AR, et al. Neuroscience from the comfort of your home: repeated, self-administered wireless dry EEG measures brain function with high fidelity. Front. Digit Health. Published online July 29, 2022. doi:10.3389/fdgth.2022.944753