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.
Software as Medical Device
Since imaging is a cornerstone clinical diagnostic tool in different therapeutic areas, Accentedge Health can bring its expertise to the table in the creation of image-based precision medicine solutions also known as software as medical device (SAMD).
Accentedge Health 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.
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.
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.