Periodic Reporting for period 2 - EDISON (“EEG-based DIagnosis Support solutiON” (EDISON) to help close the epilepsy diagnosis gap in Low- and Middle-Income Countries (LMICs) by combining low CAPEX and AI-guided capture with telemedicine)
Période du rapport: 2023-06-01 au 2025-02-28
BrainCapture aims to close the epilepsy treatment gap by providing a product that can meet the specific needs and limited resources available for epilepsy diagnosis in low- and middle-income countries (LMICs). Our solution is an affordable diagnostic service that enables portable, hospital-grade EEG-based diagnoses without an expert onsite. Our product consists of (1) a CE-marked, low-cost device for capturing medical-grade EEG recordings, consisting of an amplifier and electrode cap, (2) a proprietary smartphone application that can guide a non-expert to perform a clean and usable EEG scan, and (3) a cloud-based telemedicine solution that allows secure transfer of patient data to be read by a remote expert and provide communication between experts and the clinicians at the point of care.
We are working hard to provide an innovative product/service combination that will massively increase the availability of epilepsy diagnosis in LMICs by reducing the cost of diagnosis, bringing the necessary hardware to the point of care, and eliminating the need for on-site neurologists.
We are working hard to provide an innovative product/service combination that will massively increase the availability of epilepsy diagnosis in LMICs by reducing the cost of diagnosis, bringing the necessary hardware to the point of care, and eliminating the need for on-site neurologists.
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.
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.
The BC-1 system delivers a step change in EEG accessibility by combining hospital-grade signal quality with an ultra-portable, affordable design optimized for use in low-resource environments. Unlike traditional EEG systems, which require costly equipment, trained technicians, and hospital infrastructure, BC-1 enables non-specialist users to perform high-quality EEG recordings using a smartphone-connected amplifier and a user-guided app. The cloud-based reading platform enables asynchronous review and diagnosis by remote neurologists. This approach goes beyond the state of the art by decentralizing EEG diagnostics while maintaining clinical-grade reliability, significantly lowering the cost and complexity barriers that currently limit access in LMICs.
Additionally, the project established the foundation for BrainCapture's product AI capabilities — including seizure detection — by developing a labeled artifact dataset and an early-stage transformer-based model. To ensure broader uptake and impact, continued work is needed in areas such as clinical validation in additional geographies, streamlined local regulatory pathways, and expanded distributor networks. Access to growth financing and integration into public health frameworks will also be critical to enable scale-up and long-term sustainability.
Additionally, the project established the foundation for BrainCapture's product AI capabilities — including seizure detection — by developing a labeled artifact dataset and an early-stage transformer-based model. To ensure broader uptake and impact, continued work is needed in areas such as clinical validation in additional geographies, streamlined local regulatory pathways, and expanded distributor networks. Access to growth financing and integration into public health frameworks will also be critical to enable scale-up and long-term sustainability.