Cumulus Neuroscience’s Home Neurophysiology Platform OK’ed

Cumulus Neuroscience, a digital health company focused on advancing neuroscience clinical trials and patient care through improved data, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Cumulus EEG dry-sensor EEG headset.
 
The Cumulus EEG device is designed for self-directed use in a patient’s home or a healthcare facility. The device is now FDA-cleared for adult and adolescent patients for remote acquisition, display, and storage of electroencephalograph (EEG) data.
 
The headset is available in four sizes, and is easily self-applied in under five minutes with guidance from the Cumulus mobile app – eliminating the need for an EEG technician or healthcare professional support. This technology 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.
 
“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 of Cumulus Neuroscience told the press. “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 company also appointed Tina Sampath as its new chief commercial officer (CCO). Sampath has over 23 years of leadership experience include Gilead Sciences, Pfizer, and AliveCor.
 
“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,” said Aman Bhatti, MD, CEO, Cumulus Neuroscience. “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.”