Artera vs Visiopharm

ArteraAI Breast was cleared by FDA in May 2026 as K254115 for early-stage HR+/HER2-negative invasive breast cancer. It sorts patients into a low or high distant-metastasis risk group at a predefined cutoff, is prognostic and does not predict treatment benefit. A breast oncology team receives that result as a report from Artera's lab and runs no software.

Visiopharm is software a lab runs itself. Its apps include ER, PR, HER2 and Ki-67 scoring, the vendor says no fewer than nine diagnostic algorithms are certified under IVDR for EU and UK customers, and a 2025 J Pathol Clin Res study compared HER2-low scores from expert breast pathologists with the Visiopharm HER2 app. A pathology lab in the EU or UK scoring breast biomarkers is that buyer. The Visiopharm homepage labels products research use only unless stated otherwise, and openFDA lists no 510(k) under the applicant name Visiopharm. A US breast oncology team has K254115 to point to on the Artera side.