FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

SOPHiA Nabs CE Mark for Tumor Detection Device

April 15, 2019
A A

Biotechnology company SOPHiA has gained CE Marking for its Solid Tumor Solution (STS) tumor detection device.

The molecular diagnostic device assesses genomics and radiomics data using AI technology with statistical inference, pattern recognition and machine learning capabilities.

The STS device characterizes genomic alterations in 42 clinically relevant genes related to various solid tumors, such as lung, skin, brain and colorectal cancers.

View today's stories