Stratipath AB gained CE-IVD mark for its artificial intelligence (AI)-based software for prognostic risk stratification of breast cancers, clearing the path for introduction of the solution in the EU. Stratipath Breast analyzes digital histopathology whole slide images generated from surgically resected breast cancer tissue to identify patients with increased risk of disease progression. The system provides clearer guidance on the best treatment path for the 50% of women whose breast cancer is categorized as intermediate risk.

Fluxergy Inc. said Thursday that it has won CE-IVD marking for its one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. The automated, sample-to-action Fluxergy diagnostic testing system can run multiple assay types – such as molecular, immunochemistry, chemistry and cytometry – simultaneously on the same cartridge. The SARS-CoV2 RT-PCR test is the first CE-marked product for the Fluxergy diagnostic platform.

PARIS – Europe has turned into the epicenter of the coronavirus pandemic, seeing more than 50% of the cases observed worldwide. In fact, whereas the COVID-19 pandemic has begun declining in China where it originated, there are 400,000 cases of coronavirus worldwide, including more than 200,000 infected by SARS-CoV-2 in the 55 sovereign states in continental Europe, where they are mourning more than 18,000 deaths.