Over the course of the project, BrainCapture successfully finalized and validated a commercial ready EEG system - the BC-1.
Project Outcomes - Hardware
The hardware development phase of the project resulted in the successful creation of a CE-marked, commercially ready EEG device, consisting of a portable amplifier and electrode cap. The system was developed to meet essential safety and performance requirements and passed all necessary verification, validation, and regulatory documentation steps. Following CE certification, BrainCapture focused on adapting the hardware for real-world use by deploying units across a wide range of clinical environments. Based on direct feedback from end users, the team implemented a series of iterative improvements aimed at improving usability, durability, and long-term performance. The result is a fully compliant, field-tested device ready for broader deployment and scale-up.
Project Outcomes - Software
On the software side, the project delivered a fully functional and regulatory-compliant software stack, consisting of the BC-1 mobile application and a secure cloud platform. The Android app was developed to support non-specialist users in acquiring high-quality EEG recordings. The app underwent iterative updates to improve usability, compatibility with a wide range of Android devices, and integration with clinical workflows in LMIC contexts. In parallel, a cloud-based telemedicine platform was finalized to enable secure data storage, remote neurologist access, and centralized EEG reading. Based on feedback from pilot users and deployment partners, the software was adapted to streamline data upload processes, simplify user interfaces, and increase overall reliability in real-world environments. These improvements resulted in a robust, scalable software platform that supports decentralized EEG data capture and centralized expert diagnosis.
Project Outcomes - Regulatory
The project successfully achieved CE marking for the BC-1 system as a Class IIa medical device under the EU Medical Device Regulation (MDR). This included the implementation of a full ISO 13485-compliant Quality Management System (QMS), development of a comprehensive technical file, and successful audits by the Notified Body. Following the initial certification, BrainCapture focused on maintaining compliance as the product evolved. These achievements ensure the BC-1 system is not only compliant in the EU but also positioned for expansion into key LMIC markets. To that end, regulatory certification as also been achieved in Kenya, Indonesia, and Malaysia, with Singapore and the Philippines expected soon.
Project Outcomes - Intellectual Property
The project work generated valuable innovations and advanced BrainCapture's IP portfolio. Two patent and three trademark applications were filed, covering key aspects of the BC-1 system.
