Affordable, FDA-cleared bioamplifier: removing barriers to scalable EEG and multimodal physiological monitoring - bioamplifiers have revolutionized healthcare over the past century by enabling…

The National Institute of Mental Health awarded Openbci, Inc. $732,736 on August 1, 2026, under the Mental Health Research Grants program (CFDA 93.242) to develop Cyton V2, an affordable, FDA-cleared bioamplifier system with open-source hardware and software for clinical-grade EEG and multimodal physiological monitoring.

Openbci will design, manufacture, and obtain FDA clearance for a medical-grade, adaptable, and repairable bioamplifier system intended to address cost barriers that limit widespread deployment of clinical-grade EEG systems and to provide regulatory-compliant tools for neurotech and med-tech startups navigating product validation and market entry. The project encompasses refinement of bioamplifier design and technical specifications, design for manufacturing, and testing to achieve FDA clearance for an initial indication. The finished bioamplifier system will support cost-conscious researchers, clinicians, and medical technology innovators developing new healthcare solutions through physiological monitoring.

Work is performed in Brooklyn, New York, with a period of performance from August 1, 2026, through July 31, 2029. This is a Project Grant, the primary assistance type for NIMH research funding.

Affordable, FDA-cleared bioamplifier: removing barriers to scalable EEG and multimodal physiological monitoring - bioamplifiers have revolutionized healthcare over the past century by enabling transformative diagnostic and therapeutic tools. Among these, EEG has emerged as the most widely utilized neuroimaging modality, critical for researching, diagnosing, and treating a wide range of mental health and neurological disorders. Recent advancements in wearable electronics have expanded the potential of EEG devices, shifting from cumbersome desktop machines and wet electrodes to user-friendly, wearable devices with comfortable dry electrodes suitable for long-term, ambulatory use. Despite these technological advancements, the widespread deployment of clinical-grade EEG systems remains limited by high costs, proprietary technologies, and non-adaptable hardware. Similarly, MED-tech and neuro-tech startups often struggle to access affordable, regulatory-compliant tools for product validation and market entry, frequently failing during the "valley of death" - the critical stage in development where funding is required to meet both regulatory and market demands. Openbci aims to address these challenges with cyton V2, the first affordable, FDA-cleared bioamplifier featuring open-source hardware and software. Building on openbci's legacy of pioneering open-source physiological monitoring, cyton V2 will be a medical-grade, adaptable, and repairable bioamplifier system. IT is designed to meet the needs of cost-conscious researchers and clinicians, while also providing regulatory-compliant tools to support medical technology innovators developing new healthcare solutions through physiological monitoring. The outcome of this project will be a finished bioamplifier system that has been tested and cleared by the FDA for initial indication. The specific aims of this direct to phase II (D2P2) project are: 1. Refine bioamplifier design and technical specifications; 2. Design for manufacturability (DFM) and scale-up manufacturing processes; 3. Validate bioamplifier system quality, safety and performance to standards; and 4. Prepare and submit the final bioamplifier product for regulatory approval. By achieving these aims, this project will maximize the practical availability of medical-grade EEG and other biosensing technologies. These outcomes will address critical gaps in neurological and mental health diagnostics.