A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
Obelis has been a successful participant in the Horizon 2020 Research Program since 2014. Horizon 2020 was the EU’s largest-ever research and innovation initiative, with approximately €80 billion in financing available over seven years (2014 to 2020).
During Horizon 2020, Obelis has helped new innovative projects focusing its expertise on health technologies, including medical devices (MD), pharmaceutical, cosmetics, and advanced therapy medicinal products (ATMP).
Our Contribution to Horizon 2020
This project addresses the need of boosting innovation for the COVID-19 crisis. The main purpose is to improve the efficacy, efficiency and cost-effectiveness of the system that diagnoses and monitors the Covid-19. We have offered our regulatory expertise to ensure that the awarded projects were brought to market in a safe and compliant manner.
The finest inventions with a TRL-6 or higher (Technology Readiness Level) were chosen through two successful open calls. In both calls, an average of 200 applications was submitted by applicants from all European countries. Only 18 ideas were nominated for financing in the first round of open calls and 12 in the second.
The projects domain that received the funding were: Innovative diagnostic and screening system, Environmental Surveillance, Sensor & Devices for Telemedicine and Telepresence, Protective equipment for people and safer public. Obelis is proud to use its expertise to ensure that today’s innovation markets will help tackle the Covid-19 pandemic.
GLAM answers the Societal Challenge “Health, demographic change and well-being“, aiming to fund research that will have an impact on society, improve the quality of life of European citizens of all ages, maintain the economic sustainability of health and care systems and promote innovation through private and public sectors. The project meets a real need and urgency to have new diagnostic devices that provide diagnosis, prognosis, and monitoring data faster and with exquisite ultra-sensitivity on time to take the appropriate decisions to improve personalised diagnosis and therapy. GLAM project fully accomplishes its objective to provide an innovative device to fulfill these requirements using soluble biomarkers for personalized diagnosis and therapy monitoring.
Specifically, we designed and developed a new diagnostic tool to detect biomarkers from biofluids obtained in a non-invasive manner, specifically focusing on urine and to genitourinary cancers, to help oncologists to take better treatment decisions, approaching personalized medicine. GLAM developed an integrated device based on novel label-free photonic biosensors with ultra-sensitivity, simplicity of use, portability, multiplexing and low cost. Importantly, the GLAM unique technology makes the device also usable with other biofluids and might also be used to help physicians with another biomarker driven.
Hyposens answers the call for Information and Communication Technologies. The topics addressed in this Work Program part promote more innovation-orientation to ensure that the EU industry remains strong in the core technologies that are at the roots of future value chains.
With HypoSens, we developed a non-invasive and crucial prognostic tool for breast cancer progression in early stages to help clinicians and specially oncologists to decide about prompt therapy approaches to patients and improve quality of life and expectancy. HypoSens prognostic system consists of a non-invasive Near-infrared imaging device able to register signals through scattering media enabled by the implementation of wave front shaping, that process data collected by injected tumor-targeted body antibody functionalized nano-particles containing porphyrin sensors that determine local oxygen concentration and local temperature distribution in the cancer cells. The HypoSens imaging system is strategically designed to offer a non-invasive alternative to the Sentinel Lymph Node Biopsy, the current surgical procedure for breast cancer staging. The device is an affordable, accurate, easy to use prognostic solution for clinicians towards more accurate and fast diagnostics and personalized treatment options.
With an estimated 1.7 million new cases each year, breast cancer is the most common cancer among women worldwide. Its low cost will enable a wide and fast take-up by clinicians and hospitals leading to an important reduction of the economic and societal burden related to the diagnosis and treatment of cancer.