R&D project targets mobile early-stage cardiovascular disease diagnosis

“The InSiDe project has been triggered by the remarkable outcome of the H2020 project CARDIS. Together with the CARDIS project partners, we developed a prototype mobile, affordable, point-of-care screening device for CVD. The device enables fast and reliable measurement of CVD-related biophysical signals through minimal physical contact with the patient and minimal skills from the operator,” stated Roel Baets, Group Leader at imec and professor at Ghent University. “The objective of the InSiDe project is to take this CARDIS prototype device a major step further towards proven medical relevance and towards commercialisation.”  

The operating principle of the device is Laser Doppler Vibrometry (LDV) - a low-power laser is directed towards the skin overlying an artery. The skin’s vibration amplitude and frequency, resulting from the heartbeat, are extracted from the Doppler shift of the reflected beam. The key underlying technology is silicon photonics, which allows the implementation of advanced optical functionality in a chip produced in a CMOS fab environment. 

The CARDIS prototype device underwent a first clinical feasibility study at the Georges Pompidou European Hospital in Paris (France) and at the Academic Hospital of Maastricht (The Netherlands), collecting a substantial clinical dataset, both from healthy subjects as well as from patients with cardiovascular conditions. The quality of the device readings was found to be very good and adequate biophysical signals could be obtained in all subjects, even if the algorithmic translation to relevant markers for medical pathologies needs further work. Roel Baets added: “The very promising results from the CARDIS project stimulated the consortium to take the next step and aim at bringing the prototype to a true manufacturable product that is useful for GPs and cardiologists in their daily practice.” 

To bring the CARDIS prototype device towards commercialisation, the InSiDe project will:  

• Develop a true handheld clinical, battery-operated investigational device capable of measuring, quantifying and recording cardiovascular conditions; 
• Develop algorithms to translate the interferometer signals into data that are relevant to monitor and diagnose a number of cardiovascular diseases (CVDs); 
• Demonstrate in clinical feasibility studies the usefulness of the device for GPs and cardiologists; 
• Outline a path to industrialisation and manufacturability. 

InSiDe is supported by the European Union’s Horizon 2020 Framework Programme for Industrial leadership in Information and Communication Technologies (H2020) and by the Photonics Public Private Partnership Photonics21. 

Over the next four years, InSiDe will be managed by imec, through imec’s associated laboratory located at Ghent University (Photonics Research Group in the Department of Information Technology). Medtronic Bakken Research Center (Netherlands) will be responsible for the scientific and technical coordination of the project. Other industrial, academic and clinical partners will bring their expertise to the project: Ghent University (Belgium), Politecnico di Torino (Italy), Tyndall National Institute (Ireland), Microchip Technology (United Kingdom),  Argotech (Czech Republic),  National Institute for Health and Medical Research – INSERM (France), Universiteit Maastricht (Netherlands) and Fundico (Belgium).