Software as Medical Device
Large pharmaceutical companies present themselves more and more as broad healthcare companies rather than mere treatment providers. By offering tools that increase the understanding of an individual patient’s disease state and by linking this information to potential treatment responses, pharma companies are playing an active role in the creation of a fully personalized-medicine landscape. Since imaging is a cornerstone clinical diagnostic tool in different therapeutic areas, Radiomics can bring its expertise to the table in the creation of image-based precision medicine solutions also known as software as medical device (SAMD).
Radiomics has the potential to transfer research findings, originated from our clinical trial support services, into high quality and scalable software solutions. We use our expertise to guarantee accurate performance of these tools on images collected in daily clinical practice and assist our clients in obtaining the relevant regulatory approvals needed to make this software available for physicians.
Based on the AGILE philosophy, our software development methodology is focused on pinpointing the customer needs. Once an opportunity to transfer research findings into a software solution is identified, Radiomics’ development teams aim to build the Earliest Testable Product and improve it iteratively thanks to valuable user insights. This approach allows to speed up the development process and leads to build simpler and more efficient software solutions.
To ensure maximum reliability, our cloud-based infrastructure makes use of the latest containerization and auto-scaling technologies. Ensuring high availability while relying on tech top players security (e.g. Google).
We strive to follow best software engineering practices advised by international bodies such as IEC and IEEE. Our AGILE approach coupled with our quality management system, outlines an all-inclusive approach to encompass market and risk analysis, acceptance testing and system design considerations into planning stages. When developing solutions that require approval from regulatory bodies such as FDA or CE, we strive to ensure our solutions adhere if not surpass safety and design guidelines to deliver safe, effective and reliable tools.
Our quality management system (QMS) for medical devices and services follows the ISO 13485 standard but is also ready to be adapted to FDA and other relevant standards. The regulatory review of our QMS is on-going, and certification is expected to be completed in 2021.
We currently have one marketed medical device in Europe (COVIA) and another one under development (SUNDIAL-chemorad).
COVIA is a CE-marked medical device, developed in response to the COVID-19 pandemic. COVIA is a software that analyzes CT chest images to identify signs of COVID-19, using advanced medical images analysis algorithms. COVIA can distinguish different kinds of infections and is currently deployed at CHU Liege. During the first two waves of the pandemia over 12 000 patients have been analyzed.
Signature-0 is a cloud-based image processing software that generates a report of the prognostic score derived from patient CT data that predicts two-year survival in NSCLC patients treated by chemoradiotherapy. Software inputs and outputs are handled through an Application Programming Interface that can be easily integrated within approved third-party software/medical devices. Signature-0 is moving to the last stage of development. The product is being prepared to be CE marked in accordance with the Medical Devices Regulations (MDR) and pending FDA approval.